Quality/Regulatory Specialist

Duomed Group; Aartselaar; Sur place; EUR 45 000 - 60 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Group insurance (pension, death & guaranteed income)

DKV hospitalization insurance

Purchasing power premium

Eco-vouchers

Résumé du poste

Duomed Group in Aartselaar, Belgium is seeking a Quality/Regulatory Specialist to enhance its QA/RA team. The successful candidate will be responsible for maintaining and improving the Quality Management System according to ISO 13485 standards while ensuring compliance with relevant regulations. Strong communication skills in Dutch, French, and English are required, along with the ability to work proactively and collaboratively. The position offers a permanent contract with attractive benefits including meal vouchers and group insurance.

Qualifications

• Strong communicator, assertive yet diplomatic.
• Proactive, pragmatic, customer-oriented, and efficient.
• Ability to work independently and collaboratively in a team.

Responsabilités

• Maintain and improve Quality Management System (QMS) according to ISO 13485.
• Roll out a uniform Benelux QMS.
• Ensure compliance with applicable legislation (MDR, IVDR, Biocides, …).
• Monitor KPIs, complaints, supplier evaluations, CAPAs, and audits.

Connaissances

Fluency in Dutch

Fluency in French

Fluency in English

Strong communication

Proactive attitude

Experience with quality systems

Outils

ERP system

Description du poste

For our site in Mechelen, we are looking for an enthusiastic and driven Quality/Regulatory Specialist to strengthen our team.

Your role?

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
• 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

Your profile?

• 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.

Our offer?

• 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