Regulatory Compliance Specialist

☞ BioTalent

Aussicht: 205

Update Tag: 26-11-2025

Ort: Zaventem Flemish Brabant

Kategorie: Beratung / Kundenservice Hohe Technologie

Industrie: Pharmaceuticals Medical Devices Biotechnology

Position: Mid-Senior level

Jobtyp: Full-time

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Jobinhalt

This is a well-established medical device company based in Zaventem, Belgium. They have been able to become a leader in the industry with their gold standard, groundbreaking technology at the core. They are expanding rapidly, even doubling their growth in the past 4-5 years. This opportunity offers a lot of flexibility and the chance for an outgoing quality professional to travel to other countries, whilst working within a collaborative and passionate work environment.

Role & Responsibilities

  • writing SOPs, process mapping, controlling and revising
  • Review and assess document changes affecting EMEA procedures Assist in Management Review meetings, including collecting and collating data from different stakeholders and prepare presentation slides
  • Assist in Non-Conformance events, Corrections and CAPA’s.
  • Quality controls for release of repaired medical devices
  • Provide support for internal/external audits
  • Assists in the development, maintenance and continuous improvement of the QMS

· Interpret regulations, laws, guidelines & standards & train other employees & distributors

Skills & Requirements

  • Bachelor or equivalent in a scientific discipline preferably biological sciences, life sciences or related discipline.
  • 3 or more years’ experience in quality and compliance role within medical device or pharmaceutical industries
  • Knowledge of ISO 13485 & MDR/IVDR
  • Strong knowledge of Microsoft Applications including Excel Word PowerPoint and Visio as a software programme
  • Able to work independently and work to problem solve situations
  • Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Ability to communicate effectively and professionally in both in English (including written) and preferably another European Language
  • Experience with internal audits

If you want to be part of an innovative, growing company where you can expand your current knowledge, GET IN TOUCH - Please email me your CV at louise.cleland@biotalent.com and we can arrange confidential chat.

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Frist: 10-01-2026

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