Opportunity Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
As part of Thermo Fisher Scientific’s mission to enable our customers to make the world healthier, cleaner and safer, 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, including IVDR (EU 2017/746) and MDR (EU 2017/745, where applicable), and is accountable for EU product registrations, post-market surveillance (PMS), vigilance reporting, and Economic Operator compliance. The position partners cross-functionally to support product lifecycle management and sustainable market access across the EMEA region.
This is a site-based role with some flexibility according to our Global Policy - typically 1 day/week remote.
**Key Responsibilities**
**Regula...
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
As part of Thermo Fisher Scientific’s mission to enable our customers to make the world healthier, cleaner and safer, 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, including IVDR (EU 2017/746) and MDR (EU 2017/745, where applicable), and is accountable for EU product registrations, post-market surveillance (PMS), vigilance reporting, and Economic Operator compliance. The position partners cross-functionally to support product lifecycle management and sustainable market access across the EMEA region.
This is a site-based role with some flexibility according to our Global Policy - typically 1 day/week remote.
**Key Responsibilities**
**Regula...
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