we are looking for a Senior Regulatory Affairs Specialist Medical device.
The Senior RA specialistwill be responsible for leading global market expansion and new product introductions for Class I, Class II (US) and Class IIa (EU) medical devices. Responsibilities include planning and executing regulatory submissions for the US, EU, and other international markets, creating and maintaining technical files, managing complaints, overseeing change activities, and ensuring post market compliance. The role collaborates with cross functional teams - including QA, R&D, Clinical, Manufacturing, Operations, Marketing, and Commercial - to ensure compliant efficient, and timely market access throughout the product lifecycle, including sustained compliance.
Responsibilities:
Market Expansion & Global Regulatory Registrations:
Prepare and maintain global regulatory submissions (e.g., India, Australia, Singapore, Mexico) and author full submission packages. (e.g., EU MDR Annex II/III TD, US 510(k), ANVISA, SFDA, NMPA).
Monitor regulatory changes and ensure sustained compliance across all markets, including labeling, UDI, and post-market updates.
Conduct jurisdiction -specific impact assessment for product changes and manage global propagation of design, labeling and UDI updates.
Collaborate with R&D, Operations, Marketing, and product teams throughout new product development and commercialization to ensure regulatory alignment
Review technical documentation and ensure compliance across the full product lifecycle
Serve as the QA/RA point of contact for cross-functional programs and regulatory-related initiatives.
Maintain existing registrations, manage renewals and variations, and oversee global portfolio compliance.
Develop and execute global regulatory strategies for new market entry (US 510(k), EU MDR, Canada MDL, LATAM, APAC, MEA), including interpret country-specific requirements, identification of testing and labeling needs, and creation of submission roadmaps.
Lead pre-submission meetings and manage interactions with health authorities and notified bodies.
Ensure compliance with ISO 13485, 21 CFR 820, EU MDR, and applicable country regulations.
Requirements: 7+ years of experience in QA/RA roles within the medical device, dental, or healthcare industry with global submissions experience
Experience with ISO 13485, EU MDR, and FDA 21 CFR Part 820 requirements
Experience with global submissions and registrations of medical devices
Experience with additive manufacturing and Class I/II medical devices
Familiarity with eQMS tools and regulatory databases (e.g., EUDAMED, FDA portals)
Strong writing, documentation, and analytical skills
Demonstrated expertise in negotiating and maintaining relationships with authorized representatives, consultancy providers, including contract signing and service agreement management.
Experience with project management includint managing multiple projects
This position is open to all candidates.