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.
Post-Market Activities
Develop, implement and maintain processes to ensure compliance with applicable regulatory standards and requirements
Maintain documentation and quality records in compliance with ISO 13485, QMSR,
and internal QMS (e.g., change management, technical file updates)
Support internal audits, management reviews, and quality improvement initiatives
Participate in risk management activities and lead or support CAPA investigations, nonconformances and root cause analysis
Serve as the companys Complaint Designated Unit (CDU), managing the full lifecycle of medical devices complaints, including trend analysis, investigations, and reporting to authorities.
Participate in external audits and inspection readiness activities
Conduct regulatory gap assessments and execute remediation plans (CER updates, PMS/PMCF plans, ISO 14971 risk management).
Drive closure of regulatory-related CAPAs and support audit and inspection readiness.
Manage post-market surveillance deliverables (e.g., PSUR, vigilance reporting) and ensure timely corrective actions.
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.
