Regulatory Submissions Jobs in Bengaluru
236 Jobs Found
Trade Operations Associate
Falconx
Trade Operations Associate FalconX Location: Bangalore Experience: 4 8 Years Education: Any Graduate About FalconX FalconX is a pioneering team of operators, investors, and builders transforming institutional access to the crypto markets. Operating at the intersection of traditional finance and cutting-edge technology, FalconX simplifies the complex and fragmented digital asset ecosystem. Our platform enables seamless access, liquidity, and tools for institutional clients to execute strategies from start to scale. Role Overview As a Trade Operations Associate, you will be a key point of contact for trade settlements and operations, ensuring accurate, timely, and compliant processing of trades across internal and external systems. You will collaborate closely with Trading Desk, Product, Customer Success, Treasury, Accounting, Risk, and Compliance teams to deliver a smooth operational workflow in a fast-moving market. Key Responsibilities Handle all incoming counterparty settlement requests within agreed timeframes and manage a portfolio of counterparties. Collaborate with Trading Desk, Product, and Customer Success teams to understand and deliver on client needs. Reconcile trades, transfers, and inventory across internal subsystems and external entities such as banks and custodians. Monitor daily inventory requirements for settlement, lending, and borrowing activities, liaising with Treasury. Support Compliance and Risk teams in designing effective controls in a rapidly evolving regulatory landscape. Adhere to established trade operations processes to ensure regulatory compliance. Provide accurate trade and settlement data to Accounting and ensure timely reporting. Perform reconciliations between internal and external systems, identify breaks, and resolve issues. Continuously improve reconciliation processes, identify gaps, and implement solutions for data integrity. Requirements 4 8 years of experience in a trading firm, hedge fund, or investment bank. Strong self-management skills; comfortable organizing work with checklists and tracking progress. Experience working in fast-paced, high-pressure environments. Ability to multitask, prioritize, and manage critical day-to-day functions. Desire to gain expertise in digital assets such as Bitcoin and Ethereum. Willingness to understand the full lifecycle of institutional crypto trading operations. Serve as the first point of contact for trade settlements and operations. Gain exposure to multiple functions in a complex, dynamic market. Contribute to robust processes that ensure operational accuracy, compliance, and efficiency. Be part of a pioneering team shaping the infrastructure for institutional digital asset trading. Qualification : Any Graduate
Product Manager - Payments
Tazapay
Product Manager Payments Location: Bengaluru Work Type: Full Time Experience: 2 6 years About Tazapay Tazapay is a leading fintech platform for cross-border businesses. We provide local and global collections, holding, and payouts across multiple markets. As we expand into the digital asset ecosystem, we are building comprehensive crypto and stablecoin payment solutions to meet the growing demand for blockchain-based cross-border transactions. About the Team At Tazapay, product development is highly collaborative, involving engineering, design, partnerships, legal, risk, operations, and go-to-market teams. The cross-border payment platform team owns the core features of Tazapay s Payment Platform, including Payins, Payouts, and crypto/stablecoin infrastructure. Role Overview As Product Manager Payments, you will lead the design, development, and launch of global payment rails across both traditional and crypto/stablecoin systems. You will ensure enterprises can successfully build and operate payment operations using Tazapay s platform, bridging fiat and digital asset ecosystems. Key Responsibilities Design and launch crypto/stablecoin payment flows, including digital wallet integrations, stablecoin/blockchain settlements, and multi-chain payment solutions. Drive feature development and market launches for stablecoins like USDC, USDT, and emerging stablecoins across blockchains such as Ethereum, Polygon, and Solana. Collaborate closely with engineering, legal, sales, support, and compliance teams throughout the product lifecycle to deliver seamless payment experiences. Integrate traditional banking rails with crypto payment options, providing merchants with unified access across all payment types. Navigate and ensure compliance with global crypto regulations, working with legal and compliance teams on AML/KYC, licensing, and emerging regulatory requirements. Use a data-driven approach to analyze blockchain transactions, payment metrics, and user behavior to optimize product performance. Who You Are Minimum Requirements 2 6 years of product management experience, with at least 2 years in fast-paced fintech or crypto startups. Hands-on experience with crypto/blockchain integrations, stablecoins, wallet connectivity, smart contracts, or digital asset payment systems. Deep understanding of stablecoin ecosystems (USDC, USDT, DAI, and algorithmic stablecoins) and their underlying mechanisms. Expertise in financial API design with experience in both traditional and blockchain/crypto API integrations. Strong technical understanding of blockchain fundamentals: transaction lifecycles, gas optimization, multi-chain architecture, and consensus mechanisms. Knowledge of crypto compliance requirements and emerging global regulatory frameworks (AML/KYC, licensing, etc.). Analytical mindset with ability to leverage blockchain and payment data to drive product decisions. Preferred Qualifications Degree in Computer Science, Engineering, Finance, or related field, with blockchain coursework or certifications. Proven track record of launching successful crypto/stablecoin payment products or features at scale. Hands-on experience with major blockchain networks, ecosystems, development tools, and integration patterns. Experience collaborating with crypto exchanges, wallet providers, or blockchain infrastructure companies. Qualification : Degree in Computer Science, Engineering, Finance, or related field, with blockchain coursework or certifications
Senior Associate - Legal
Zolve Innovations
Position: Senior Associate Legal Location: Bengaluru Employment Type: Full-Time About Zolve Zolve is the world s first **cross-border neo-bank**, enabling migrants and global citizens to access financial products credit, checking accounts, insurance, and loans based on their home-country credit score. By breaking geographic boundaries, Zolve empowers users to navigate financial systems across countries seamlessly. As Zolve expands, we are seeking a Senior Associate Legal to provide legal support for our partner ecosystem and internal business operations. Role Overview The Senior Associate Legal will support Zolve s business teams by **drafting, reviewing, and negotiating contracts**, advising on cross-border legal and regulatory matters, and ensuring compliance with applicable laws. This role is ideal for a proactive, adaptable legal professional with a **startup mindset** who can balance legal expertise with fast-paced business needs. Key Responsibilities Contracting & Legal Advisory **Draft, review, and negotiate** a wide variety of agreements, including SaaS, IT services, IP licenses, collaboration, staffing, marketing, hardware, and NDAs. Advise business teams on key legal and regulatory matters, aligning inputs with strategic growth priorities. Provide support on contract disputes, **dispute resolution, and litigation** where required. Cross-Border Compliance Advise on **cross-border legal and regulatory matters**, including **data protection, FEMA, RBI guidelines**, and other applicable financial regulations. Gain exposure to international contracting frameworks, particularly across **APAC and EU regions**. Stakeholder Engagement Collaborate with senior leadership and business teams to ensure legal inputs are **practical and aligned with business objectives**. Support risk assessment, due diligence, and compliance initiatives. Qualifications Education: **Bachelor s degree in Law (LLB)** or equivalent. Master s degree or professional certification (e.g., Bar Admission) preferred. Experience: **2 5 years of post-qualification experience**. Experience in **fintech, financial services, or technology sectors** preferred. In-house counsel or top-tier law firm background is advantageous. Exposure to APAC or EU contracting frameworks is desirable. Skills & Competencies: Strong **drafting, negotiation, and risk assessment skills**. Knowledge of **financial regulations, data protection, and corporate governance**. Excellent research, analytical, and communication skills. Ability to manage multiple priorities independently. **Startup mindset**: proactive, adaptable, outcome-driven, and eager to learn. High ethical standards and professional integrity. Qualification : Bachelors degree in Law (LLB) or equivalent
Senior Regulatory Affairs Specialist
Alivecor India
Senior Regulatory Affairs Specialist Location: Bangalore Company: AliveCor About AliveCor & The Opportunity AliveCor is a pioneer in **over-the-counter medical ECG devices**, dedicated to making heart health accessible. The company s **FDA-cleared medical-grade hardware and software** have enabled millions of heart health measurements, making a life-saving impact. We are seeking a **Senior Regulatory Affairs Specialist** to join our growing team. This is a critical role focused on **shaping regulatory strategy** for innovative mobile health technologies, managing product submissions, and ensuring compliance with international regulatory standards, including **ISO 13485 and FDA** Quality Systems. Role & Responsibilities As a Senior Regulatory Affairs Specialist, you will: Collaborate & Execute Regulatory Strategies: Work with product teams to **develop and execute global regulatory strategies** for registrations in the US, Europe, and other key regions. Manage Regulatory Submissions: Participate in the preparation and review of **global regulatory submissions**, including **510(k), de novo**, and other medical device filings. Support Government Interactions: Serve as the point of contact for regulatory agencies such as the **FDA, EU MDR**, and other international authorities, ensuring timely product approvals and licenses. Global Market Registrations: Drive product **registrations and renewals** for worldwide markets, supporting distributors with compliance documentation. Review & Approve Technical Documents: Assist in reviewing advertising, promotional materials, and technical documentation to ensure **compliance with applicable regulations**. ISO 13485 & FDA Compliance: Help implement and maintain an **ISO 13485 and FDA-compliant Quality Management System (QMS)**. Product Development Support: Collaborate with cross-functional teams (Engineering, Product, Quality) to support regulatory requirements during product development and design changes. Post-Market Compliance: Assist in post-market regulatory actions, including compliance with **reporting requirements and audits**. Requirements & Qualifications Experience & Education Experience: **4+ years in Regulatory Affairs within the medical device industry.** Education: Bachelor s degree in Science, Engineering, Math, or a medical field, or equivalent experience. Regulatory Experience with AI/ML: Experience in regulatory affairs for **software devices with AI/machine learning algorithms (SaMD)**. Core Regulatory Knowledge Global Regulatory Knowledge: Experience with **EU Medical Device Regulations (MDR)** and familiarity with regulatory processes in the US, EU, and Asia-Pacific regions. Regulatory Submissions: Experience preparing **510(k) submissions, pre-submissions, or de novo submissions** for medical devices. Skills Project Management: Ability to manage small projects with a focus on being organized, independent, and results-oriented. Analytical & Communication Skills: Excellent analytical, communication, and team collaboration skills, with a keen **attention to detail**. Preferred Qualifications Advanced Degree: Master s degree or regulatory affairs certifications such as **RAPS** (Regulatory Affairs Professionals Society). International Submissions: Experience in international submissions, especially in Asia-Pacific or LATAM regions. Perks & Benefits Working Model: Hybrid Working Model (Flexibility to work both remotely and in the office). Family Leave: Comprehensive Family Leave policies. Medical Benefits: Above-market family floater medical insurance, including coverage for parents/in-law parents. Office Perks: Complimentary lunch provided at the office and convenient metro connectivity. Qualification : Bachelors degree in Science, Engineering, Math, or a medical field, or equivalent experience
Quality Manager
Irp Systems
Quality Manager Location: Bangalore Department: Operations About the Role IRP Systems, at the forefront of **high-performance e-powertrain systems**, is seeking an experienced **Quality Manager** to oversee all quality assurance and control activities in its automotive manufacturing environment. You will be instrumental in ensuring products meet **customer and regulatory standards** while continuously driving improvements in processes, reliability, and customer satisfaction. Key Responsibilities Quality Management System (QMS): Develop, implement, and maintain the QMS according to **IATF 16949**, **ISO 9001**, and customer-specific requirements. Quality Team Leadership: Lead and manage a team of quality engineers, inspectors, and technicians, ensuring adherence to quality standards and consistency. APQP & Core Tools: Manage **Advanced Product Quality Planning (APQP)**, **PPAP**, and **FMEA** activities to integrate quality into every stage of the product lifecycle. Quality Metrics Monitoring: Track and analyze key quality metrics (e.g., **scrap rate, PPM, customer complaints, warranty data**). Drive corrective actions for continuous improvement. Audits: Lead internal and external audits (**IATF, ISO, customer, and supplier audits**), ensuring full compliance with all quality standards. Customer Interface: Serve as the primary point of contact for customers regarding **quality issues** and performance reviews. Supplier Quality Management: Oversee **supplier qualification, audits, and corrective actions** to ensure quality consistency throughout the supply chain. Root Cause Analysis & CAPA: Facilitate **root cause analysis** and lead the implementation of **Corrective and Preventive Actions (CAPA)** to resolve issues and prevent recurrence. Continuous Improvement: Promote and lead a culture of continuous improvement using methodologies like **Lean, Six Sigma**, and problem-solving tools (**8D, 5 Whys, PDCA**). Compliance: Ensure compliance with all relevant safety, environmental, and regulatory standards applicable to the automotive industry. Skills and Qualifications Experience & Education Education: Bachelor s degree in Electronics Engineering or related fields. Experience: Minimum of **8 years in a Quality leadership role** within the automotive industry, and at least **10 years of experience in electronics and mechanical manufacturing**. Certifications & Standards Expertise Certifications: **Six Sigma Green/Black Belt certification is required.** Standards Expertise: Extensive knowledge of automotive quality standards (especially **IATF 16949**) and familiarity with **ISO 26262 (Functional Safety)**. Technical & Analytical Skills Quality Tools Proficiency: Expertise in using core quality tools such as **8D, APQP, FMEA, SPC, and MSA**. Manufacturing Knowledge: Familiarity with advanced manufacturing processes and technologies relevant to the automotive industry. Analytical Skills: Strong problem-solving and analytical skills to effectively address and resolve customer quality issues. Impactful Work: Contribute to the development of **high-performance e-powertrain systems**. Career Growth: Be part of a dynamic and rapidly growing company with opportunities for professional development. Competitive Benefits: Competitive compensation, flexible working options, and health coverage. Qualification : Bachelors degree in Electronics Engineering or related fields
Medical Review Physician 1
Clinchoice
Medical Review Physician 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a detail-oriented and experienced Medical Review Physician to join our pharmacovigilance team in Bangalore. In this role, you will be responsible for the medical evaluation of individual case safety reports (ICSRs) across multiple data sources and therapeutic areas, ensuring compliance with global regulatory standards and internal quality benchmarks. Key Responsibilities Medical Review & Safety Assessment Perform medical review of both serious and non-serious ICSRs, with a focus on seriousness, expectedness, causality, and narrative quality. Review ICSRs originating from multiple sources: spontaneous reports, literature, regulatory authorities, solicited sources, and clinical trials. Evaluate and verify the selection of adverse events from source documents, assign appropriate MedDRA codes, assess product labelling, and review narratives for accuracy and completeness. Support triage activities and determine seriousness and relatedness across assigned products. Product & Process Expertise Maintain up-to-date knowledge of product portfolios and safety profiles across therapeutic areas, including Oncology, Respiratory, Immunology, Neuroscience, and Rare Diseases. Ensure timely completion of all medical review activities in line with regulatory timelines and service level agreements (SLAs). Contribute to process improvement initiatives, including implementation of quality control checks and feedback mechanisms. Collaboration & Training Provide expert medical guidance to case processors, data entry associates, and quality reviewers to address queries and discrepancies. Mentor and train team members in GVP concepts, case processing standards, and disease-specific medical knowledge. Collaborate with internal functional teams and client therapeutic groups to resolve case-related issues efficiently. Compliance & Quality Stay updated with ICH-GCP, GVP modules, 21 CFR, and other relevant regulatory guidelines. Deliver consistent, high-quality output while ensuring compliance with client-specific conventions and global safety standards. Take on additional tasks as assigned by the team lead/manager, adapting to shifting business priorities when necessary. Candidate Profile Education: MBBS or MD is required. Experience: 2 4 years of hands-on experience as a Medical Reviewer for ICSRs. Regulatory Knowledge: Strong understanding of ICH-GCP, Good Pharmacovigilance Practices (GVP), 21 CFR, and other international regulatory requirements. Technical Skills: Proficient in MS Office Suite (Outlook, Excel, Word, PowerPoint). Soft Skills: Excellent analytical, communication, and mentoring skills; ability to work independently and as part of a cross-functional team. Be part of a high-impact team contributing to global drug safety. Collaborate across a wide range of therapeutic areas and product portfolios. Develop and grow within a supportive, knowledge-driven work environment. Engage in continuous learning and professional development in a critical area of healthcare. Qualification : MBBS or MD is required
Lead/associate Manager - Case Processing1
Clinchoice
Lead/Associate Manager Case Processing 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a dynamic and experienced Lead/Associate Manager Case Processing to join our Pharmacovigilance team in Bengaluru. This role requires deep domain knowledge, leadership capability, and hands-on experience in handling Individual Case Safety Reports (ICSRs) across various sources. The ideal candidate will be responsible for managing day-to-day operations, ensuring compliance with global regulatory requirements, and mentoring a team of case processors. Key Responsibilities Operational Oversight Oversee and ensure the timely processing of ICSRs in accordance with SLA/KPI metrics. Allocate tasks effectively across the team to meet project deliverables and workload requirements. Proactively monitor team performance and work closely with team members to resolve operational or domain-related challenges. Risk & Issue Management Identify, escalate, and mitigate risks related to deliverables, compliance, or resourcing. Serve as a point of contact for internal stakeholders and clients regarding operational queries or escalations. Team Leadership & Performance Management Conduct regular performance evaluations, provide constructive feedback, and support career development of team members. Guide and mentor the team and Subject Matter Experts (SMEs) in ICSR processes, compliance standards, and MedDRA coding. Support functional capability development within the team and leadership pipeline. Training & Quality Assurance Conduct process and project-specific training as needed to ensure team competence and readiness. Ensure adherence to quality standards by contributing to quality system documentation, SOPs, and procedural updates. Provide feedback and suggestions to strengthen client/internal workflows and ensure continuous improvement. Process Improvement & Strategic Contribution Suggest and implement process enhancements to improve efficiency, accuracy, and compliance. Contribute to the development of scalable and sustainable pharmacovigilance processes. Collaborate cross-functionally to support strategic goals and business growth initiatives. Required Experience & Knowledge In-depth understanding of ICH-GCP, GVP modules, 21 CFR, and relevant global regulatory requirements. Proven expertise in managing high-volume ICSR workloads, including serious, non-serious, and potentially serious reports. Experience processing ICSRs from diverse sources: spontaneous, literature, solicited, regulatory authorities, and clinical trials. Exposure to therapeutic areas such as rare diseases and oncology is highly desirable. Experience in literature screening and review would be an added advantage. Proficient in MS Office applications (Excel, Word, Outlook, PowerPoint). Candidate Profile Education: Master s degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements. Experience: 10 12 years of relevant experience in pharmacovigilance, case processing, or related functions. Strong leadership skills with a proven ability to train, mentor, and manage cross-functional teams. Demonstrated ability to allocate resources, manage competing priorities, and maintain high-quality standards. Proactive, process-driven mindset with a commitment to continuous improvement and regulatory compliance. Work with a global leader in drug safety and pharmacovigilance services. Lead high-performing teams and contribute to the delivery of impactful healthcare solutions. Be part of a collaborative environment that values innovation, learning, and operational excellence. Apply now to lead meaningful work that impacts patient safety around the world. Qualification : Masters degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements
Associate Credit Operations
Bright Money
Associate Credit Operations Job Type: Full-Time Category: Operations Location: Bangalore About Bright Bright is a consumer fintech company dedicated to helping Americans get out of debt using advanced data science and machine learning. Our mobile app integrates all the tools needed for managing and eliminating debt covering credit score building, automated debt paydown plans, financial and budget planning, and loan refinancing across credit cards, student loans, and car loans. With 300,000+ users, 6x growth in the last year, and over 100,000 ratings and reviews, Bright is one of the fastest-growing fintech platforms in the U.S. Supported by top venture capital firms like Sequoia, Falcon Edge, and Hummingbird, Bright has raised over $40 million in funding, including a recent $50M debt financing from Encina Lender Finance. Bright is ranked among the top 8 U.S. fintech companies and is poised to become a top-100 financial institution by leveraging data science and predictive modeling. We are proud to be building the first large-scale consumer tech company from India for global markets. About Our Founders Bright was founded in 2019 by industry veterans from McKinsey s Banking Practice and data scientists from InMobi: Petko Plachkov, Avi Patchava, Varun Modi, Avinash Ramakath, and Jayashree Merwade. Role Overview As an Associate Credit Operations professional, you will play a crucial role in assessing creditworthiness, supporting loan underwriting and approval, and ensuring smooth credit operations. You will work closely with cross-functional teams to monitor credit metrics, facilitate collections, and drive improvements in operational efficiency. Key Responsibilities Conduct thorough creditworthiness assessments following company policies and guidelines. Review customer profiles and credit applications against underwriting standards. Manage loan approval processes and support decision-making with sound judgment. Utilize collection systems to assist in managing delinquent accounts and dues recovery. Monitor and report on credit-related performance metrics regularly. Handle customer conflicts and disputes with a strong customer-centric approach. Investigate customer requests by gathering relevant data and exploring all information sources. Identify opportunities for process improvements to increase efficiency and effectiveness. Collaborate with teams to ensure compliance with credit policies and regulatory requirements. 1-2 years of experience in credit assessment, underwriting, or a related role. Strong understanding of credit product workflows and end-to-end process flows. Familiarity with credit risk assessment principles and banking domain knowledge. Knowledge of the U.S. credit environment and regulatory framework is a plus. Excellent verbal and written communication skills. High analytical and investigative capabilities. Ability to manage credit-related metrics and performance indicators. Strong negotiation, interpersonal skills, and ability to handle conflicts diplomatically. Join a fast-growing fintech startup backed by leading investors. Gain exposure to credit operations and risk management in a global context. Work alongside experienced professionals passionate about transforming consumer finance. Opportunity to grow within a dynamic, collaborative environment.
Manager - Custody
Coindcx
Manager Custody Experience: 3 7 years Location: Bengaluru Team: Operations & Risk About CoinDCX At CoinDCX, we believe Change Starts Together. Our mission is to make Web3 and digital assets more accessible, secure, and user-friendly for everyone. In just six years, we've grown from India s first crypto unicorn to a leading platform with over 125 million users. As we continue to scale our impact, we re building the next generation of secure, scalable, and compliant Web3 infrastructure and we want you to be part of it. About the Role As Manager Custody, you will be responsible for overseeing digital asset custody operations, ensuring optimal deployment on Earn products, maintaining comprehensive risk monitoring, and aligning with regulatory compliance standards. This role is critical to safeguarding assets, improving operational efficiency, and scaling our Earn offerings in a rapidly evolving regulatory and technical landscape. Key Responsibilities 1. Token Deployment & Custody Operations Ensure 100% deployment of tokens across the Earn platform. Develop and execute token allocation strategies for staking, liquidity pools, and other avenues. Liaise with trading and portfolio management teams to identify deployment opportunities. Maintain accurate custody records and ensure timely, reliable disbursals. Create investment memos (IMs) for Earn deployments and work with the risk committee for approvals. Establish and maintain SOPs for custody and Earn operations. 2. Risk Monitoring & Incident Management Design and maintain a comprehensive risk monitoring framework with full coverage. Monitor for operational, technical, and counterparty risks in real-time. Conduct risk assessments for new deployments and token integrations. Manage incident response and ensure resolution of custody-related risk events within 24 hours. Deliver periodic risk reports to internal stakeholders and leadership. 3. Operational Excellence & Compliance Manage day-to-day custody operations in line with regulatory and internal policies. Interface with external custodians, service providers, and compliance bodies. Implement continuous improvement initiatives to drive process efficiency and accuracy. Ensure full documentation and audit readiness for all custody activities. 4. Cross-functional Collaboration Partner with Technology, Product, Compliance, and Risk teams to drive system improvements. Contribute to enhancements of Earn products from an operational and security standpoint. Support regulatory and audit processes through timely reporting and coordination. Performance Metrics 100% Token Deployment on Earn products 100% Risk Monitoring coverage Deployment Efficiency Ratio (actual vs. target) Risk Event Resolution Time (
Director Quality Engineer
Coindcx
Director Quality Engineering Experience: 15 20 years Location: Bengaluru Team: Engineering About CoinDCX At CoinDCX, we believe Change Starts Together. We are on a mission to make Web3 accessible to all, building cutting-edge products that solve real-world challenges in security, scalability, and user accessibility. In just six years, we ve transformed from India s first crypto unicorn to a platform serving over 125 million users worldwide. As we accelerate Web3 adoption, we are looking for visionary leaders to help us maintain world-class quality and performance standards. Role Overview As Director of Quality Engineering, you will lead and scale our QA and Performance Engineering functions to ensure the reliability, scalability, and security of our fintech products. You ll be responsible for driving the quality strategy across large-scale distributed systems and building a high-performing team passionate about excellence. What You ll Do Leadership & Strategy Lead and grow a team of 50+ QA, automation, and performance engineers. Define and execute a long-term quality engineering strategy aligned with business goals and regulatory requirements. Foster a culture of ownership, accountability, and continuous improvement. Quality Engineering Champion an automation-first approach across functional, regression, and integration testing. Oversee end-to-end validation for core product flows including trading, payments, custody, and compliance. Own testing strategies for microservices architectures and high-throughput APIs. Performance & Scalability Lead performance testing initiatives designed to support systems handling over 1 million TPS with sub-50ms latency. Develop frameworks for continuous performance benchmarking and capacity planning. Collaborate with SRE, DevOps, and Product Engineering to identify and mitigate performance bottlenecks. Non-Functional Testing Ensure comprehensive coverage for reliability, availability, failover, disaster recovery, and security. Drive chaos testing, fault injection, and compliance-related quality assurance processes. Collaboration & Stakeholder Management Partner with Product, Platform, Security, and Compliance teams to align quality standards with regulatory mandates. Provide executive reporting on quality, system resilience, and risk metrics. Influence cross-functional adoption of best practices in testing and release validation. What You Bring Experience 15+ years in QA and Performance Engineering, with at least 5 years in senior leadership roles. Proven experience managing large, high-growth fintech or financial services engineering teams (50+ members). Technical Expertise Deep expertise in testing large-scale distributed systems. Strong knowledge of performance, load, stress, soak, and chaos testing frameworks. Familiarity with cloud-native environments (AWS, Kubernetes), CI/CD pipelines, and observability tools. Domain Knowledge Extensive background in fintech or financial services (trading, payments, banking). Strong understanding of regulatory and compliance requirements in financial applications. Leadership & Soft Skills Exceptional people leadership, mentoring, and organizational scaling capabilities. Excellent stakeholder management with the ability to influence senior engineering and business leaders. Strategic, data-driven decision-making mindset. You re passionate and constantly curious about Web3 and Virtual Digital Assets (VDA). You act with ownership, drive excellence, and focus on measurable impact. You embrace a We over Me philosophy empowering your team as you grow. Change excites you and fuels your innovation mindset. You think beyond limits, challenging the status quo to push boundaries. Perks That Empower You Design Your Own Benefit: Personalize your perks to fit your lifestyle whether it s tech, travel, or pets, your priorities come first. Unlimited Wellness Leaves: Take time off as needed to recharge your health matters most. Mental Wellness Support: Access free counseling, expert sessions, workshops, and social events to stay balanced. Bi-Weekly Learning Sessions: Sharpen your skills and stay current with ongoing industry trends and knowledge. Join Us If you re ready to lead a high-impact team and help build the future of Web3 quality engineering we want to HODL you on our team!
Manager Legal
Jindal Aluminium
Position: Manager Legal Department: Legal and Corporate Relations Location: Bengaluru Role Overview: We are looking for an experienced Manager Legal to manage litigation and non-litigation legal matters, with a strong focus on land revenue issues, property disputes, regulatory compliance, and contract management. The ideal candidate will possess in-depth knowledge of land laws, property documentation, and dispute resolution, ensuring the company s legal interests are effectively safeguarded. Key Responsibilities: Oversee and manage all legal matters related to the company, ensuring compliance with applicable laws and regulations. Handle legal issues related to land revenue, including land acquisition, property registration, title verification, and encumbrance checks. Ensure compliance with state and central land revenue laws, municipal regulations, and other relevant legal frameworks. Manage land dispute resolution by coordinating with local authorities and providing legal representation in court or other forums as required. Handle litigation matters, including preparation of case files, drafting of petitions, affidavits, and legal submissions. Represent the organization in court proceedings, arbitrations, and other legal forums. Draft, review, and negotiate legal documents such as sale deeds, lease agreements, Memorandums of Understanding (MoUs), and other land-related contracts. Conduct legal due diligence on property transactions to ensure clear title ownership and risk mitigation. Collaborate with cross-functional teams to facilitate smooth property transactions and legal compliance. Provide timely legal advice on various company matters as required. Manage relationships and coordinate with external legal counsel for both litigation and non-litigation matters. Maintain and update legal documentation, property records, and compliance registers to ensure accuracy and accessibility. Qualifications: Bachelor of Laws (LLB) degree from a recognized institution. Proven experience handling land revenue laws, property documentation, and dispute resolution. Strong litigation management skills with the ability to represent the company effectively. Excellent negotiation, drafting, and communication skills. Ability to work collaboratively with internal teams and external legal advisors. Qualification : Bachelor of Laws (LLB) degree from a recognized institution.
Assistant Company Secretary
Shopup
Assistant Company Secretary Location: Bengaluru, India Company: ShopUp HQ Role Overview As an Assistant Company Secretary at ShopUp, you'll be pivotal in ensuring our group of private limited companies strictly adheres to corporate governance and regulatory compliance. You'll facilitate seamless communication between the Board of Directors, shareholders, and regulatory bodies, managing all aspects of board and shareholder meetings, statutory filings, and governance practices. This role is key to maintaining operational excellence and supporting the company s legal and compliance framework. Key Responsibilities Organize and coordinate Board of Directors meetings and General Meetings of shareholders as per applicable regulations. Ensure timely distribution of meeting notices, agendas, and related documents to the Board and shareholders. Accurately record, maintain, and preserve minutes of Board and shareholder meetings in compliance with regulatory standards. Manage share capital structure, including share allotments, transfers, and dividend processing for all group entities. Advise and support Board members on their statutory duties and governance obligations under the laws enforced by the Registrar of Joint Stock Companies (RJSC). Execute contracts, agreements, and lease documents on behalf of the company as authorized. Communicate Board decisions effectively to relevant departments for timely implementation. Maintain well-organized records of all corporate governance documents and correspondence. Guide company staff in understanding and fulfilling governance and compliance responsibilities. Champion best practices in corporate governance through monitoring, advising, and timely reporting. Facilitate the preparation, publication, and dissemination of annual reports and shareholder communications. Ensure timely and accurate submission of all regulatory filings, license renewals, and compliance reports. Liaise proactively with regulatory authorities including BSEC, DSE, CSE, CDBL, RJSC, and BIDA, keeping the Board informed of any regulatory or statutory updates. Undertake any other tasks assigned by senior management related to governance and compliance. Qualifications & Experience Educational Qualification:Master s degree in Business Administration, Law, or a related field from a reputed university or institution, either domestic or international. Professional Experience:Minimum 5 years of relevant experience in company secretarial practice, corporate governance, or compliance management. Qualification : Masters degree in Business Administration, Law, or a related field from a reputed university or institution, either domestic or international.
Engineer - Power Thermal
Qualcomm
Software Engineer Power/Thermal Software Products Team Company Qualcomm India Private Limited Job Area Engineering Group > Software Engineering General Summary As a leading technology innovator, Qualcomm pushes the boundaries of what's possible to enable next-generation experiences and drive digital transformation to help create a smarter, connected future for all. As a Qualcomm Software Engineer, you will design, develop, create, modify, and validate embedded and cloud edge software, applications, and/or specialized utility programs that launch cutting-edge, world-class products that meet and exceed customer needs. You will collaborate with systems, hardware, architecture, test engineers, and other teams to design system-level software solutions and obtain information on performance requirements and interfaces. Minimum Qualifications Bachelor's degree in Engineering, Information Systems, Computer Science, or related field and 2+ years of Software Engineering or related work experience. OR Master s degree in Engineering, Information Systems, Computer Science, or related field and 1+ year of Software Engineering or related work experience. OR PhD in Engineering, Information Systems, Computer Science, or related field. 2+ years of academic or work experience with Programming Languages such as C, C++, Java, Python, etc. Job Description Job Overview: The Power/Thermal Software Products Team at Qualcomm focuses on delivering industry-leading power, thermal, and limit software management solutions across Qualcomm s Mobile, Automotive, Compute, IoT, and AR/VR chipsets. In this role, you will work with cross-functional teams to: Identify power optimization and performance tuning opportunities. Perform thermal/limits hardware tuning, characterization, and risk assessment. Develop optimized solutions and mitigation strategies. Conduct system-level analysis of power/thermal use cases. Collaborate with Architecture, Hardware Design, Performance, Power/Thermal Systems, and various Software teams to create optimal system-level power/thermal software solutions. Develop tools and methodologies for competitive analysis to understand competitors strengths and weaknesses. Design and implement thermal mitigation schemes that are best in the industry. Preferred Qualifications 3+ years of experience with Programming Languages such as C, C++, Java, Python, etc. Strong systems/hardware background with a solid understanding of microprocessor architecture and common SoC hardware blocks (interconnects, display, graphics, etc.). Good understanding of operating system concepts including scheduling, memory management, process management, interrupt handling, and device drivers. Experience using debug tools such as JTAG debuggers, oscilloscopes, and logic analyzers. Experience developing power/thermal management software. In-depth knowledge of embedded systems, microcontrollers, SoC power, modems, multimedia, wireless communications, and system-level debugging/analysis for SoC power optimization. Equal Opportunity Employer Statement Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, Qualcomm is committed to providing an accessible process. You may email [email protected] or call Qualcomm s toll-free number found on their website. Upon request, reasonable accommodations will be provided to support individuals with disabilities during the hiring process. Qualcomm is also committed to ensuring its workplace is accessible to individuals with disabilities. (Please note that this email address is exclusively for accommodation requests. Qualcomm will not respond to requests for application status updates or resume inquiries via this email.) Recruitment Policy Qualcomm s Careers Site is only for individuals seeking employment directly with Qualcomm. Staffing and recruiting agencies, as well as candidates represented by agencies, are not authorized to use this site to submit profiles, applications, or resumes. Any such submissions will be considered unsolicited. Qualcomm does not accept unsolicited resumes or applications from agencies and is not responsible for any associated fees. Compliance Notice Qualcomm employees are expected to comply with all applicable policies and procedures, including but not limited to security requirements and protection of company confidential and proprietary information, in line with applicable laws. Qualification : Bachelor's degree in Engineering, Information Systems, Computer Science, or related field and 2+ years of Software Engineering or related work experience.
Senior Sql Java Application Support Engineer
Oracle India
About Oracle FSGBU and Banking Consulting NACA: Oracle Financial Services Global Business Unit (FSGBU) is a world leader in providing IT solutions to the Financial Services industry. Oracle s customers include ten of the top ten Global Banks, ten of the top ten Insurance companies, ten of the top ten Securities firms, five of the top five Mutual Fund companies and four of the top five World Stock Exchanges. With the experience of delivering value-based IT solutions to over 840 financial institutions in over 130 countries, the FSGBU understands the specific challenges that financial institutions face: the need for building customer intimacy and competitive advantage through cost-effective solutions while, simultaneously, adhering to the stringent demands of a dynamic regulatory environment. Our solutions have the world's most comprehensive and contemporary banking applications and provide a technology footprint that addresses their complex IT and business requirements. Banking Consulting NACA which is a part of Americas Region under FSGBU - Consulting delivers Oracle Technology and Applications solutions for clientele in the North America, South America and Caribbean region. The service offerings include Application Implementation, Managed Services and Customization development services for Oracle Financial Services Software Banking products. Your Opportunity This gives you an opportunity to apply your technology knowledge, skills and experience to work in the Banking Consulting team with a new generation of Oracle Banking products in next generation architecture built leveraging the latest technologies. Utilize your communication and service skills to provide support in addition to problem solving and technical skills. Our Ideal Candidate Should have excellent communication and presentation skills and can willing to go that extra mile to attain perfection. Effective verbal and written communication skills. Should be bilingual. Able to have effective written and verbal communication in Spanish and English. Proactive, willing to take ownership, ability to quickly learn new technologies and take up new tasks and initiatives. Should have excellent problem solving, analytical and technical troubleshooting skills. Ready for working in shifts. Your Responsibilities Be primary point of contact for a portfolio of Enterprise clients, coordinating with the L3 support teams to drive issues to resolution. Provide immediate assistance to end users for incidents / problems involving FLEXCUBE/OFSLL products. Perform first level analysis and diagnosis of incidents / problems for end-users. Collaborate daily with the L3 support & development teams to ensure proper information is available to them to triage and fix software bugs. Maintain and create documentation around technical troubleshooting and best practices. Keep technical documentation and procedures up to date. Provide technical assistance as needed for troubleshooting and customer service. Ensure technical problems are resolved in a timely manner. Provide input regarding methods to increase operational efficiencies and technical product improvements. Become internal expert on supporting FLEXCUBE, OFSLL software. Use defined standards/tools/processes to achieve deliverables that meet quality expectations of Oracle / Client. Document all work in accordance with agreed standards/processes applicable for Oracle / Client. Adhere to defined Change Control Process of Oracle / Client. Comply with Oracle / Client audit / Compliance requirements. Perform proper handover / knowledge transfer at end of each assignment. Timely status reporting to supervisor. Timely submission of timesheets and expenses for Oracle / Clients. Your Qualifications Mandatory A minimum of 2 years working experience as L2 application support engineer for Banking/Financials services application. Able to perform Issue Tracking on Application and follow-up for resolution of same with stakeholders. Experience in supporting Web-based business applications. Moderate knowledge in writing complex SQL queries. Working knowledge in UNIX Operating System. Skilled in creating and maintaining technical documentation. Should be bilingual. Able to have effective written and verbal communication in Spanish and English. Optional Possess good understanding of Core Banking. Experience with web services. Prior experience in supporting FLEXCUBE, OFSLL products is an added advantage. Soft/Behavioral Skills Works under pressure and can manage SLA s. Customer-friendly communication and attitude. Strong analytical skills, attention to detail - a problem solver. Excellent organization skills, ability to systematize and prioritize. Customer service experience and problem-solving skills. Patience and understanding. Investigation and diagnostic skills. Ability to multi-task and work with team to meet deadlines. Experience Experience of 2 to 4 years. Experience as L2 application support engineer for Banking/Financials services application. Educational and Other Qualifications Master s in computer application (MCA) or Engineering in computer science field or BS Computer Science with a 3.0 GPA or other relevant degree. Work Environment Should be willing to work remotely as well as travel to client locations. Should be willing to take up FLEXCUBE Technical certifications in functional areas as and when required. Ability to work in a high pressure, fast moving and challenging environment. Ready for on call support during off business hours on a need basis. Ready to work in shifts. Team player. Job Location: Bangalore, Chennai, Mumbai Qualification : Masters in computer application (MCA) or Engineering in computer science field or BS Computer Science with a 3.0 GPA or other relevant degree.
Risk Management & Compliance Analyst
Johnson & Johnson Services, Inc
Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Johnson & Johnson is recruiting for some great opportunities for its Global Services (GS) in Bangalore, India which is well equipped with the latest technology and modern infrastructure. This is your chance to work with the best talent in a workforce that reflects the diverse markets Johnson & Johnson serves around the world, and an inclusive culture that values different perspectives and life experiences. Reimagine the possibilities at Johnson and Johnson Global Finance! We live this motto every day by creating exciting business solutions for the world s largest and most broadly-based healthcare company. As a member of our Global Finance team, you will have exclusive access to a network of financial professionals located in over 60 countries. This new network will help you build on your current skills and explore opportunities to grow your career in J&J. At J&J Global Finance, we value ideas for innovation and improvement and are committed to diversity and inclusion. Together we will reinvent business processes to become more effective, more efficient, and improve customer experience. We are proud to be an equal opportunity employer. The Global Services Finance organization provides best-in-class, cost-effective financial services, and compliance support in a J&J way to our Operating Companies around the world. Risk Management & Compliance (RM&C) is one of such initiative under Global Services Finance. RM&C, ASPAC is seeking a Risk Management & Compliance Analyst who will have responsibility for fulfilment of the SOX and Compliance programs across J&J entities, training and advisory along with all Compliance related support to different sectors and performing walkthroughs, sampling, testing the effectiveness of control deployment, documentation of testing results, remediation support, monitoring, audit support, project support etc. Key Responsibilities 1. Be compliant with applicable laws and regulations, and follow guidelines in the J&J Credo 2. Maintain Operational Excellence Deep expertise and knowledge of the Worldwide Procedures and compliance requirements for respective areas. Identify compliance risks and recommend solutions to remediate / prevent breach. Ensure strong internal controls are in place and maintain compliant environment across the Organisation. Responsible for performing Compliance Health Checks and other internal reviews to test the effectiveness of the control placement. Support timely closing & execution of financial periods as per closing calendar and in accordance with SLA commitments, fully observing Compliance, Internal Audit & SOX requirements. Accountable for supporting completeness, accuracy and validity of the actuals reported within process/entity scope. Work closely with all business process and IT team members to communicate compliance requirements, documentation standards, sign-offs and review processes. Provide trainings to all business process owners for any change/update in financial procedures. Support projects, business partnering with collaborators, assisting business process owners with adoption of J&J policies & procedures. Support in standard Compliance document requirements: Risk Control Matrix, Hand-off s, SOPs and submission of required SOX templates (system inventory templates, SOX questionnaires etc.). Performs control walkthrough, operational testing and discusses the findings with the process owners. Conduct compliance due diligence for transitions in-scope. Testing of preventive & detective UA/SOD Controls (e.g. granting, facilitating appropriateness & semi-annual reviews) across all ERP systems. Support Sectors during Corporate Financial Audits. Supervise and drive the Corrective Action Plan (CAP) process, to ensure audit(internal & external) recommendations and key control gaps per SOX testing are implemented and other internal control gaps are closed timely and effectively. Be A Trusted Business Partner Implement global Strategy & Solutions in line with taxonomy. Support Process Subject Matter Experts (SME's) and Operational Key Contacts (OKC's) to ensure cross sector, cross region, and cross process alignment, ensuring good documentation is maintained and consistency of a global approach Create radical Innovation Generate ideas, fosters, and implements continuous improvement attitude, identifying and pursuing process efficiency opportunities. Manage operational improvements, generating ideas and implementing in line with global standards. Qualifications Qualifications Education A minimum of a Bachelor s level degree or equivalent is required, preferably in accounting, finance, or related business subject area. ACA, CPA and/or other financial certifications is highly preferred. Required At least 1 - 3 years of post qualification experience is required: Strong knowledge and understanding of accounting and financial processes (for Trading as well as Manufacturing business), shared services and related subject matter Understanding of internal controls, risk management, US GAAP accounting, financial systems, IT development and/or production support Clear understanding of SOX 404 requirements Understanding of audit procedures and auditing practices Experience in developing and managing audit programs desirable Experience in performing audits of financial processes and systems required, preferably in manufacturing/trading/service industry At least 1 year Management / Supervisory / team handling experience i...
Senior Statistical Programmer
Icon Plc.
About ICON: ICON is a world-leading healthcare intelligence and clinical research organization that accelerates the development of drugs and medical devices aimed at improving quality of life and saving lives. We offer outsourced services to pharmaceutical, biotechnology, medical device companies, and government/public health organizations. At the core of ICON s success is our people driven by passion, excellence, and a strong mission to succeed. Role Overview: The Senior ADaM Programmer will be responsible for creating and validating Safety and Efficacy analysis datasets, tables, listings, and figures in adherence with CDISC and client-specific standards. This position requires advanced skills in programming, effective time management, and proactive problem-solving to ensure high-quality deliverables in line with project timelines. Key Responsibilities: Programming & Data Analysis: Create and Validate ADaM Datasets for safety and efficacy domains, ensuring high quality and accuracy. Develop Safety and Efficacy Tables, Listings, and Figures to meet study specifications. Design and finalize study-specific macros and programming specifications/mock-ups. Troubleshoot and resolve programming issues in a timely and efficient manner. Adhere to programming specifications and study-specific requirements, ensuring complete documentation. Project Management & Collaboration: Plan, organize, and allocate tasks to ensure effective resource planning and adherence to project timelines. Proactively track workload and progress in accordance with KPIs and quality standards. Collaborate effectively with the biostatistics team, remote teams, senior programming staff, management, and sponsors to achieve study goals. Quality Control & Documentation: Maintain quality control and ensure the datasets are accurate and meet CDISC standards. Ensure compliance with industry regulations, standard operating procedures, and best practices in clinical programming. Required Qualifications: 6+ years of experience in ADaM programming and R. Strong proficiency in SAS programming, including SAS/Base, PROC SQL, SAS/Stat, SAS Macros, and SAS/Graph (both basic and advanced). Experience in creating ADaM datasets for safety and efficacy domains. Strong problem-solving skills, with attention to detail and ability to work independently and as part of a team. Verbal and written communication skills that ensure effective collaboration across teams and stakeholders. Benefits of Working at ICON: At ICON, we prioritize continuous learning and professional development. Our total reward package includes: Competitive base salary along with variable pay and recognition programs. Comprehensive benefits including health insurance, retirement planning, and more. Employee wellbeing initiatives that support you and your family throughout your career. A collaborative, inclusive work culture where diversity and career growth are encouraged. Diversity & Inclusion at ICON: ICON is an equal opportunity employer, committed to creating a workplace free from discrimination and harassment. We value diversity and encourage applicants from all backgrounds to apply. All qualified applicants will receive equal consideration for employment, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. How to Apply: If you're ready to contribute your skills to global healthcare solutions, apply now to join the ICON team and make a meaningful impact on patients lives around the world. This role presents an exciting opportunity for professionals looking to advance their programming career within a global leader in clinical research.
Statistical Programmer Ii
Icon Plc.
About ICON: ICON is a world leader in healthcare intelligence and clinical research. We are at the forefront of advancing clinical research, providing essential outsourced services to the pharmaceutical, biotechnology, and medical device industries. ICON s success is driven by the dedication and expertise of its people, who share a commitment to improving the lives of patients. Role Overview: As a Jr. Statistical Programmer, you will contribute to clinical research by performing programming tasks related to statistical analysis. You will be responsible for ensuring timely completion of programming activities, maintaining compliance with industry standards, and assisting with the development of clinical trial data. This role is ideal for someone with 3+ years of SAS Programming and R experience, looking to grow in the clinical research field. Key Responsibilities: Programming and Analysis: Develop an understanding of applicable policies, procedures, and industry standards. Complete programming tasks under supervision, ensuring accuracy and timely completion. Demonstrate programming expertise with a focus on SAS and R, assisting with statistical analysis tasks. Identify gaps in current programming practices and propose improvements. Adhere to industry standards, and stay updated with evolving best practices and regulations. Team Collaboration: Work effectively as part of a team, contributing to the success of clinical studies. Take responsibility for your assigned tasks, ensuring they are completed on time and in alignment with the team s goals. Required Qualifications: 3+ years of experience in SAS Programming and R. Strong programming and domain expertise in statistical programming. Ability to execute a wide range of programming activities with minimal supervision. Awareness of evolving industry standards and the ability to suggest improvements to existing practices. Benefits of Working at ICON: Competitive salary with variable pay and recognition programs. Comprehensive benefits package, including health insurance and retirement planning. Work-life balance initiatives, including flexible working hours and additional country-specific benefits such as childcare vouchers, gym memberships, and health assessments. Access to Global Employee Assistance Programme (TELUS Health), offering 24-hour support from a global network of specialists. Life assurance and other family-focused benefits. Why Choose ICON? ICON is committed to building a diverse and inclusive culture where talent is nurtured and rewarded. Our success depends on the collective strength of our people, and we offer ample opportunities for growth and career development. If you are passionate about making a difference in clinical research and want to work in a dynamic, supportive environment, we encourage you to apply. Qualification : 3+ years of experience in SAS Programming and R.
Sr. Regulatory Technical Program Manager
Ericsson-worldwide
We are excited to announce an opportunity for a talented individual to join Ericsson as a Technology Specialist. This unique role offers the chance to provide technology leadership in sectors that are of strategic importance to our company. You will be instrumental in the development of innovative solutions, components, and products using cutting-edge technology. As a Technology Specialist, you will significantly contribute to the strategic planning to ensure the competitiveness of our product portfolio. This role requires a global nomination and appointment, with further details available . What you will do: - Drive technology leadership, becoming an in-house spokesperson and advisor to senior management. - Contribute to strategic planning and ensure a competitive product portfolio through technical investigations and task force contributions. - Align technology strategies with product and development goals, influencing Ericsson s research activities. - Judge and introduce new technology advances when they become mature and cost-efficient. - Provide in-depth technical solutions for complex problems and drive the innovation process. - Represent the company in relations with customers and educational institutions, and uphold our position as a technology leader. The skills you bring: Qualification: Bachelor's degree in Electrical / Wireless Communication Engineering. Minimum 8 years of experience in project management within a regulatory environment with specialized knowledge in wireless communication technologies, including Bluetooth, Wi-Fi, and GSM (4G and 5G). Strong knowledge of Wireless global regulatory requirements and experience with regulatory submissions. Excellent organizational, analytical, and problem-solving skills. Excellent written and verbal communication skills, including the ability to interact effectively with global functional teams. Outstanding teamwork and collaboration skills. Proficiency in Microsoft Office 365. Qualification : Bachelor's degree in Electrical / Wireless Communication Engineering.
Senior Regulatory Specialist
Philips
Job Description Job title: Senior Regulatory Specialist Your role: The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW. Author 510k submissions, led pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications and lead interactions with regulators/competent authorities throughout review and approval process. Participate in strategic product development, design solutions starting from concept phase to product delivery phase and provide regulatory guidance throughout design and development. Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to the other RA Staff and project team. Able to manage special projects across spectrum of product lines. Monitor global regulatory landscapes and guide cross-functional team on implementation of regulation changes. Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements. Supports product defect assessments, issue impact assessments, health hazard evaluations, corrections and removals and CAPAs as a regulatory subject matter expert. Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements. Identify areas for improvement for efficiency and compliance in internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. Lead or participate on process improvement teams to affect changes at a local or cross business unit level. Opportunity for mentoring and coaching other regulatory team members and provide regulatory guidance. You're the right fit if: Minimum of 7-10 years of experience in the Regulatory Affairs medical device industry with regulatory submission experience 510(k) experience is preferred. Preferred candidate will have a master s degree in engineering or regulatory affairs or a related field with minimum of 7 years of experience. Will consider applicants Bachelors Degree with demonstrated experience working within Medical Device industry. Mastery in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulations, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations. Prior experience supporting/leading regulatory submissions such as 510(k), EU MDR Technical Documentations and global registrations Strong written, oral, and interpersonal skills required to work in a team environment as well as individual contributor with minimal supervision. Solution and detail oriented, well organized and self-motivated with ability to negotiate with regulators. May require up to 20% travel How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Qualification : Preferred candidate will have a masters degree in engineering or regulatory affairs or a related field with minimum of 7 years of experience.
Senior Statistician
Glaxosmithkline Plc
About GSK GSK is a global biopharma company with a shared purpose: to unite science, technology, and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by 2030 and deliver sustainable returns for our shareholders. At GSK, we focus on preventing diseases as well as treating them. Our success depends on our people, and we want GSK to be a place where individuals feel inspired, valued, and challenged to grow both professionally and personally. We offer a dynamic environment where employees can thrive, grow, and look after their wellbeing. Biostatistics Group (India) GSK's Biostatistics team in India is an integral part of the global Biostatistics function with a legacy of over 20 years. Our team, recognized for its strong leadership, talent, and high energy levels, plays a crucial role in therapeutically aligned, cross-functional, and global teams. We are seeking individuals at various levels, from new graduates to senior and managerial roles, who are passionate about innovation and technology and want to make a difference in patients lives. Role Overview As a Senior Statistician, you will play a pivotal role in the design, execution, analysis, and interpretation of clinical trials. You will have the opportunity to work with a broad range of statistical methodologies and collaborate with global teams to influence clinical development plans and strategies. The role involves working closely with internal and external partners to provide statistical input, ensuring the success of clinical studies. Basic Qualifications PhD in Statistics (with or without relevant experience) OR MSc in Statistics with more than 4 years of relevant experience in the design, execution, analysis, and interpretation of clinical trials. Expertise in a broad range of statistical methodologies, including: Experimental design Mixed models Bayesian methods Linear and nonlinear regression Excellent interpersonal and communication skills. Proven ability to build and maintain strong working relationships. Ability to explain novel and standard methods to both fellow statisticians and cross-functional teams. Strong influencing skills, applied effectively across all levels of the organization. Preferred Qualifications Experience in methodologies such as: Experimental design Mixed models Bayesian methods Linear and nonlinear regression Repeated measures Experience with modeling, simulation, and other innovative methodologies. Evidence of statistical innovation and technical expertise in clinical trials. Experience in regulatory submissions and interactions with regulatory bodies. Experience working with and coordinating Contract Research Organizations (CROs). Strong time management skills and the ability to manage multiple tasks across different projects. Key Responsibilities Provide statistical input to the design, analysis, reporting, and interpretation of clinical studies. Influence clinical development plans, regulatory, and commercial strategies. Build and maintain effective strategic relationships with internal and external partners. Develop and implement novel statistical methodologies to support medicines development. Stay updated with the latest developments in the field of statistics and explore their applicability within the organization. Manage conflicting demands and priorities while developing creative solutions to problems. At GSK, we are united in our responsibility to create healthier futures. If you are driven by a passion for science, innovation, and making a positive impact, GSK provides an exciting opportunity to grow your career while contributing to global health. Qualification : PhD (Statistics) with or without relevant experience (OR) MSc (Statistics) with >4 yrs relevant experience for Senior Statistician in the design, execution, analysis, and interpretation of clinical trials
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