20 beste vacatures voor de functie van operator in gemeente katwijk (nieuwe medewerkers gezocht)

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Manager, Regulatory Affairs EMEA

Thermo Fisher Scientific -
Bleiswijk

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Vacaturegegevens

Fulltime

Kwalificaties

Supplychain
Biomedische technologie
Engels
Projectmanagement
Bachelor
Veiligheid
Gegevensverzameling
Communicatieve vaardigheden

Volledige vacaturetekst

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

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!

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Ik wil de nieuwste vacature-alerts ontvangen voor de functie van operator in gemeente katwijk

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