- Our consultants work depending on their background and experience on a range of projects from supporting our clients with compliance issues, building quality systems in compliance with ISO 13485, building technical files for CE or 510(k) submissions for the US, providing strategic advise on registration and market access of medical devices, doing audits and giving training or workshops.
- If you have a technical background, (some) experience in medical device regulations and/or quality assurance and you are looking for a new challenge that brings flexibility and diversity in clients, devices, projects, then our company has a dynamic work environment in which you can learn and develop and operate in the innovative fast moving medical device sector.
We are looking for enthusiastic professionals who meet the following criteria:
- Technical education with a BSc, MSc or PhD degree (physics, mechanical engineering, chemistry, biology, etc)
- Minimal 5 years working experience in a medical device company
- Quality and/or regulatory experience with medical devices
- Pragmatic, enjoying a mix of activities in technology, business processes, regulatory affairs.
- Communicative and service oriented, supporting a wide variety of clients from small start-ups to large multi-nationals, able to adapt to different company cultures and situations.
- Strong organizational skills, detailed oriented to deal with various projects at the same time
- Fluent in Dutch and English
- Working permit and driver’s license