Quality & Regulatory Affairs Specialist Raamsdonksveer • QTC Recruitment
Gevraagd
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Fulltime
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Ervaren/Expert
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Engels (taal)
Aanbod
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Loondienst (vast)
Vacature in het kort
Over het bedrijf
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QTC are partnered with an innovative medical device scale-up focused within medicinal liquids for oral administration. They are actively seeking a new Quality & Regulatory Affairs Specialist, responsible for maintaining and improving the company’s Quality Management System (QMS) and ensuring full compliance with EU Medical Device Regulation (MDR). You’ll play a key role in audit readiness, manage the transition of products from Class I to Class IIa, and support continuous improvement across the organisation.
This is how you will make the difference
Key responsibilities:
- Maintain and enhance the company’s QMS in line with ISO 13485 and applicable regulations.
- Ensure ongoing audit readiness for internal, external, and notified body audits.
- Oversee document control, CAPA management, and continuous improvement processes.
- Lead regulatory activities related to the transition from Class I to Class IIa medical devices.
- Prepare and maintain technical documentation, product registration files, and regulatory submissions.
What you bring
Key requirements:
Bachelor’s or Master’s degree in Life Sciences, Engineering, Regulatory Affairs, or related discipline.
Minimum 3 years’ experience in Quality and/or Regulatory Affairs within the medical device industry.
Strong knowledge of ISO 13485 and EU MDR, including experience managing QMS and regulatory transitions.
Excellent organisational, communication, and documentation skills.
Proactive, detail-oriented, and collaborative team player.
What's in it for you
What’s on Offer:
Competitive salary and benefits package.
The opportunity to lead critical regulatory projects during an exciting phase of growth.
Professional development and training opportunities.
Supportive, collaborative company culture.
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