Manager, Regulatory Affairs EMEA

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.

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!