Senior Regulatory Affairs Specialist Job in 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.