Manager, Regulatory Affairs EMEA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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

Regulatory Strategy & Product Registration

• Lead EU regulatory strategy and execution for LSG IVD and/or MD products.
• Serve as the primary regulatory contact with EU Competent Authorities and/or Notified Bodies.
• Support new product introductions and lifecycle changes to maintain EU market access.
• Support EUDAMED registrations and UDI compliance as required
• Monitor changes in EU regulatory requirements and assess their impact on the product portfolio.
  
  

Post-Market Surveillance (PMS)

• Oversee and manage Post-Market Surveillance activities for IVD and/or MD products in accordance with IVDR/MDR requirements and/or applicable requirements.
• Ensure PMS plans, reports (PMSR/PSUR), and trend analyses are developed and maintained appropriately.
• Collaborate with Quality and Medical Affairs to ensure effective post-market data collection and evaluation.
  
  

Vigilance Reporting

• Lead EU vigilance reporting activities, including serious incident reporting and Field Safety Corrective Actions (FSCA).
• Ensure timely submission of reports to Competent Authorities and/or coordination with Notified Bodies.
• Drive compliance with EU/MEA vigilance timelines and internal SOPs.
  
  

Economic Operators Compliance

• Serve as the primary liaison between LSG and the EC Authorized Representative (EU AR), ensuring effective communication and regulatory alignment.
• Act as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative.
• Support compliance of Economic Operators (Manufacturer, Authorized Representative, Importer, Distributor) under IVDR/MDR requirements.
• Provide guidance to internal and external stakeholders regarding EU regulatory obligations.
  
  

Cross-Functional Partnership & Compliance

• Collaborate cross-functionally with Quality, Clinical, R&D, Supply Chain, and Commercial teams to ensure regulatory compliance throughout the product lifecycle.
• Support all business units of LSG to comply with regulatory requirements of the IVDD/IVDR, MDD/MDR, national legislation in EU countries.
• Support internal audits, external audits, and regulatory inspections.
• Provide regulatory guidance and training to internal stakeholders as needed.
• Monitor regulatory intelligence and assess impact of regulatory changes on the portfolio.
• Recruits, coaches and develops organizational talent.
  
  

Qualifications & Requirements

• Bachelor’s degree or above in Life Sciences, Biomedical Engineering, Pharmacy, or related field.
• Minimum 8 years of experience preferred in Regulatory Affairs within the medical device and/or IVD industry.
• Strong knowledge of EU IVDR (EU 2017/746) and MDR (EU 2017/745) regulations.
• Demonstrated experience in EU product registration and lifecycle management.
• Hands-on experience with Post-Market Surveillance and Vigilance reporting.
• Strong project management skills with the ability to manage multiple priorities.
• Excellent communication skills in English (written and verbal).
• Ability to work independently and collaboratively in a cross-functional, global environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization as well with external authorities.
• Willingness to travel up to 30%.
  
  

Preferred Qualifications

• Experience in managing regulatory teams and/or projects in a matrix organization.
• Experience working with EU Competent Authorities and Notified Bodies is preferred.
• Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization.
  
  

Apply now!