Vacature - Jouw nieuwe functie
Regulatory Consultant Medical Devices
17 JAN '23: This organisation was founded in 2011. Though young and dynamic, the consultancy embodies decades and decades of experience. Not only do they have regulatory expertise in both product development as well as maintenance, but they also are strong when it comes to pharmacovigilance. Rather than performing a task, they work with clients proactively to bring business to the next level. They value a personal approach with attention to their clients' needs.
Medical Devices
Oss - Netherlands
40 uur per week
Over jouw rol
Zo maak jij het verschil
Wat nodig is
Wat jij mee brengt
- have an MSc/PhD in Pharmacy, Chemistry, Medical Biology, Life Sciences;
- will prepare and update technical documentation (eg. STED, BSER, CER, RMP);
- will coordinate and manage interactions with notified bodies;
- implement and maintain ISO 13485 quality management systems;
- perform IVD and medical device directive vs. regulation gap analysis.
Wat wij bieden
Jouw voordelen
- A competitive salary;
- Laptop and company phone;
- 25 holiday days;
- Pension.
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