Sr Regulatory Affairs Specialist-Medical Devices

☞ Thermofisher Scientific

Ver: 180

Dia de atualização: 26-11-2025

Localização: Brussels Brussels Capital

Categoria: Legal / Contratos

Indústria: Information Technology Services Biotechnology Pharmaceuticals

Posição: Associate

Tipo de empregos: Full-time

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Conteúdo do emprego

The Job

The Senior Regulatory Specialist is a role in our Life Science Solutions Group. The purpose of this role will to be responsible for managing In-Vitro Diagnostic (IVD) Medical Device regulatory submissions and regulatory compliance activities in line with corporate and divisional objectives.

In addition, the position will provide regulatory support to customers with respect to legislative requirements for the market place, mainly EMEA.

Location:

Can be located anywhere in the UK remote or Warrington or near London

What will you do?
  • Compile, review and maintain regulatory submissions, Technical Files, and labelling for completeness and quality.
  •  Maintain and update dossiers for existing Marketing Authorizations.
  • Identify regulatory requirements for new product and changes to existing products.
  • Determine the scope of information/documentation necessary to file new registration applications and post-approval changes to regulatory agencies.
  • Contribute within new product development projects to ensure compliance with internal product commercialization process (PCP) and global regulations.
  • Review and approve product labelling/marketing materials for compliance with applicable regulations and standards.
  •  Review new and existing EMEA regulations, guidance documents and standards, and prepare comments based on impact to product and business.
  •  Support post-market surveillance and vigilance activities, including submitting reports to authorities.
  • Participate in internal and external company regulatory/quality audits, and assist corporate in carrying out GMP cross-site audits.
  • Participate in customer audits/technical meetings when applicable.
  • Develop regulatory affairs internal policies and procedures, and provide internal trainings as and when required.
  • May be required to perform other related duties as required and/or assigned.
  • Has contact with all levels of company employees as well as frequent interactions with varies external regulatory agencies, authorities, distributors and customers.
Who We Are Looking For

Minimum Requirements/Qualifications:
  • Bachelor’s degree in Biology or similar field, from an accredited college or university or equivalent experience.
  • A strong working knowledge of Medical Device regulatory affairs environment including but not exclusive to:  Regulations, Submissions and Technical Files.
  • Experience of communicating with Regulatory Authorities and Distributors 
  • Experience in clinical trials, specifically regulatory activities and submissions for the trials
  • Experience in regulatory audits, ISO certification, GMP requirements and document control.
  • Knowledge of In Vitro Diagnostic will be an asset
  • Warrington office or Remote.  Some travel required: ~ 20%.   
What’s in it for you?

We offer excellent opportunities to progress your career along with training and a chance to be a part of a growing successful organization.

About Us

As the world leader in serving science, our work is more than something that fills our days.  When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Each one of our 70,000 extraordinary minds has a unique story to tell. It’s not just a career, it’s a chance to realize your best – professionally and personally.

Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer. Apply today!
  • IND-EMEA
Job Summary

Job number: 163955BR

Date posted : 2021-06-14

Profession: Quality & Regulatory

Employment type: Full-Time

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Data limite: 10-01-2026

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