FDA Jobs in Pune

Job Description: 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. Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents. Lead 510(k) submission, preparation of EU MDR Technical Documentation, Health Canada license applications and other global registrations and work with global regulators/competent authorities throughout review and approval process. Supports activities required to maintain regulatory compliance as new or revised versions of standards, guidance documents are published. Monitor global regulatory landscapes and supports implementation of regulation changes and executes quality plans to minimize business impact. Provides Regulatory assessment of product changes for launch and sustaining activities. 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. May lead or participate in process improvement teams to affect changes at a local or cross business unit level. Job Requirements/Qualifications: Minimum of 15+yrs years of experience in the medical device industry with regulatory submission experience. 510(k) submission experience preferred. Minimum of a bachelor s degree in engineering or a related scientific field. Degree within Regulatory Affairs and/or Regulatory Affairs Certification is preferred. Proficiency in understanding, interpretation, and the 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 510k, EU MDR Technical Documentation and global registrations Strong written, oral, and interpersonal communication skills to be able to work in a team environment. Solution and detail oriented, well organized and self-motivated. 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 : Minimum of a bachelors degree in engineering or a related scientific field. Degree within Regulatory Affairs and/or Regulatory Affairs Certification is preferred.

Job Description Job Title: Electrical Designer You are a part of Hardware Engineering Group under MRI Business, located at Philips Healthcare Innovation Centre (HIC) Pune. HIC is playing a key role in Philips global strategy for Diagnostic Imaging. With Philips HIC, the foundation was laid to touch billions of lives and reiterate Philips commitment towards healthcare growth markets Your Role: Requirements, design, implementation, test and integration of module/sub-system in accordance with the higher-level architectural requirements and design specifications. Ensuring that the design is consistent with the higher-level architecture and requirements. Ensuring that the proposed design would have the safety, reliability and quality features built-in. Responsible for ensuring that the design meets the performance, quality and cost criteria. Conduct concept and feasibility studies. Leads the introduction of new technologies. Ensuring that there is proper documentation per standards for the developed design. Ensuring the mutual consistency and efficient integration of the separate components in modular design that meets the product specification. Ensuring that his/her design modules meet the product certification requirements. Drawing up personal schedule and reports on progress. Defining and assessing the Work Breakdown Structure/planning/costs of his/her area. Being abreast of technical developments in own field through study of literature and technical contacts. Maintaining product and company reputation by complying with country specific regulations. Supplier evaluation and communication. You're the right fit if: Completed Engineering studies at university level; B.E. / B. Tech. / M.E. / M. Tech. in Electronics or Electrical Engineering with 8+ years of experience. Knowledge of state-of-the-art methods/tools (CAD/simulation) used in Electrical, PCB and Cable harness design. Experience in New Product Introduction (NPI), Product Life Cycle Management, Obsolescence Management/Sustenance and Value Engineering. Exposure to Analog, Mixed Signal Board Design and Power Electronics designs. Experience in 16/32-bit microcontroller-based design and interfacing. Knowledge of Cable harness design for power, analog-digital signal, Communication, RF, audio/video and fiber optics cabling. Working knowledge on the selection of electronic components, cable and connectors. Knowledge of communication interfaces like RS232, RS485, CAN, EtherCAT, Ethernet and USB. Knowledge of EMI/EMC standards and testing for conformance. Hands-on experience in schematics and PCB design tools (e.g. Cadence / mentor Graphics). Ability to understand and debug problems across hardware/software boundaries. Should have experience in DFMEA and design of Fail-safe systems and Sub-systems. Should have good fundamental knowledge of Motors/Motor Drivers/ Position, Speed Encoders and should be able to analyze motor under different operating modes such as regenerative mode. Experience in design of a communication gateway will be an added advantage. Should have experience in design of high-speed digital interface. Knowledge of mechanical design compatibility aspects. Knowledge of IEC 60601 standards will be an added advantage. Knowledge of Embedded Software Programming will be an added advantage. Ability to understand and debug problems across hardware/software boundaries. Global and Cross-functional Experience/Skills in a Matrix Organization will be an added advantage. Knowledge of Global Medical Quality and Regulatory Standards e.g. IEC, FDA, UL, CE, CSA etc. will be an added advantage. Hands-on experience with tools like Agile, Clear-quest, Windchill or equivalent. Disciplined team worker, ability to work independently. Result oriented team player. Ability to present and articulate ideas to key stakeholders and leadership team. Excellent communication skills and Positive can do attitude. Quality mindset in design and documentation. 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 : Completed Engineering studies at university level; B.E. / B. Tech. / M.E. / M. Tech. in Electronics or Electrical Engineering with 8+ years of experience.