The Manager, Regulatory Affairs – EMEA is responsible for leading regulatory activities for the LSG IVD and/or MD medical device portfolio within the EMEA region
Job Summary
The Manager, Regulatory Affairs – EMEA is responsible for leading regulatory activities for the LSG IVD and/or MD medical device portfolio within the EMEA region.
This role ensures compliance with applicable EU regulations and is accountable for EU product registrations and post-market surveillance.
The position collaborates cross-functionally to support product lifecycle management and sustainable market access across the EMEA region.
Matching Summary
The Manager, Regulatory Affairs – EMEA is responsible for leading regulatory activities for the LSG IVD and/or MD medical device portfolio within the EMEA region.
Skills & Requirements
Must-have
EU regulatory strategy
Post-Market Surveillance activities
Vigilance reporting
Nice-to-have
Managing regulatory teams
Collaboration in matrix organization
Strong project management skills
Key Requirements
Bachelor’s degree in Life Sciences
Minimum 8 years of experience in Regulatory Affairs