Voor een klant ten noorden van Antwerpen zijn wij op zoek naar drie freelance consultants, het betreft onderstaande rollen.
Gedetailleerde job descriptions zijn beschikbaar op aanvraag, en de functies kunnen verder toegelicht worden door onze verantwoordelijke RA/QA consultant.
Opstartdatum zo snel mogelijk, minstens halftijds (voorkeur is voltijds) en verwachte duurtijd van het project is 6 maanden.
MDR Clinical Evaluator
A detail-oriented and experienced MDR Clinical Evaluator to support the clinical evaluation of arterial/venous cannulae in compliance with EU Medical Device Regulation (EU MDR 2017/745). The ideal candidate will have a strong background in clinical research, regulatory documentation, and medical writing, with specific expertise in vascular access devices or similar Class IIa/IIb medical devices.
Risk and usability engineer
A highly skilled **Usability & Risk Manager** with deep expertise in **Medical Device Regulation (EU MDR 2017/745)** to lead usability engineering and risk management activities for our portfolio of **cannulae**. This role is critical to ensuring that our devices are safe, effective, and user-friendly across their lifecycle, in full compliance with regulatory standards.
RA Specialist
A proactive and detail-oriented Regulatory Specialist to support regulatory compliance activities for our medical device portfolio under the European Medical Device Regulation (EU MDR 2017/745). This role is essential to ensuring our products meet all applicable regulatory requirements throughout their lifecycle, from development to post-market.