Quality/Regulatory Specialist

As a Quality/Regulatory Specialist, you are the driving force behind our quality and regulatory policy. You ensure that our organization not only meets the highest standards but also continuously improves.

A concrete selection of your responsibilities:

• Maintain, implement, and improve our Quality Management System (QMS) according to ISO 13485
• Roll out a uniform Benelux QMS
• Draft processes, policies, and work instructions
• Monitor KPIs, complaints, supplier evaluations, CAPAs, and audits
• Challenge the status quo and initiate improvement actions
• Implement ISO 14001 in Belgium
• Train and raise awareness among colleagues about the QA/RA mindset
• Ensure compliance with applicable legislation (MDR, IVDR, Biocides, …)
• Manage quality mailboxes and ensure proper follow‑up
• Set up and manage the product library and QMS processes
• Translate business strategy into operational processes
• Keep regulations up to date and implement updates
• Optimize processes in collaboration with other departments

• You are a strong communicator, assertive yet diplomatic.
• You can express yourself fluently in Dutch, French, and English (both spoken and written).
• You are proactive, pragmatic, customer-oriented, and efficient.
• You can work independently and take ownership, while also being a true team player.
• Experience with quality systems is a must. Knowledge of MDR legislation or ISO 13485 and ISO 14001 is a plus.
• You have (initial) experience with an ERP system.
• You are available full-time.

• A place in our young and dynamic RAQA team, where collaboration and support are key
• A versatile role with extensive interaction within the Benelux and with other Duomed affiliates
• Opportunities to learn, grow, and take initiative, supported by both internal and external training (products, ERP, …)
• An open and collegial atmosphere where well being and performance go hand in hand
• The chance to contribute to the growth story of a company with an excellent reputation in the medical world
• A permanent contract with attractive benefits:
  • Meal vouchers
  • Group insurance (pension, death & guaranteed income) and DKV hospitalization insurance
  • Purchasing power premium and eco vouchers

Interested Send your CV and motivation letter to: Duomed Benelux – Attn. Ms. Nele Coosemans