Vacature - Jouw nieuwe functie
Quality & Regulatory Affairs Specialist
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.
Medical Devices
Quality/RA
Raamsdonksveer - Netherlands
40 uur per week
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Jouw consultant
Over jouw rol
Zo maak jij het verschil
- 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.
Wat nodig is
Wat jij mee brengt
- 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.
Wat wij bieden
Jouw voordelen
- 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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