This role is responsible for leading the regulatory market access team driving complex global regulatory submissions for IVD and Medical Device portfolios
Job Summary
This role is responsible for leading the regulatory market access team driving complex global regulatory submissions for IVD and Medical Device portfolios.
Lead development and execution of global regulatory strategies for product registrations, renewals, and change controls across major markets.
Manage regulatory specialists through on-the-job training and review of deliverables to meet business goals.
Matching Summary
This role is responsible for leading the regulatory market access team driving complex global regulatory submissions for IVD and Medical Device portfolios.
Skills & Requirements
Must-have
Global regulatory strategies
MDR, IVDR, and regional frameworks
End-to-end submission lifecycle management
Partnering with R&D, Quality, Manufacturing
Coordination with Notified Bodies and health authorities
Nice-to-have
Mentoring junior team members
Process improvement identification
Digital submission platforms proficiency
Key Requirements
Minimum 12 years of experience in global Regulatory Affairs for IVDs and Medical Devices
Proven track record in hands-on submission execution and authority communication
Strong understanding of MDR, IVDR, FDA 510(k)/PMA, and other regional product registration pathways
Experience managing simultaneous submissions across multiple geographies
Degree in Life Sciences, Regulatory Affairs, or Biomedical Engineering; advanced degree preferred