Manager, Regulatory Affairs EMEA
Core
Leading regulatory activities for LSG IVD and/or MD medical device portfolios to ensure EU compliance, product registration, and market access.
Role type
Manager, Regulatory Affairs
Builds
EU market access and regulatory compliance for medical devices and IVDs
Domain
Medical Devices / In Vitro Diagnostics / EU Regulatory
Deliverable
client delivery
Required skills
EU IVDR/MDR regulation expertise, EU product registration, Post-Market Surveillance management, Vigilance reporting, Economic Operator compliance, Cross-functional collaboration, Project management
Preferred skills
Team management in matrix organizations, Experience with EU Competent Authorities and Notified Bodies
Technologies
EUDAMED, UDI
Responsibilities
Lead EU regulatory strategy and execution for LSG IVD and/or MD products; Oversee Post-Market Surveillance activities; Lead EU vigilance reporting and Field Safety Corrective Actions; Serve as Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative; Collaborate cross-functionally with Quality, Clinical, R&D, Supply Chain, and Commercial teams; Recruit, coach, and develop organizational talent.
Seniority
Manager, team leadership