Work on the development and certification of active medical devices and/or in vitro diagnostic products. Safeguard product safety, identify applicable regulations and prepare the technical file for certification within a multidisciplinary team in Enschede.
The role
As a QA/RA Engineer, you will be part of a quality team and work on multidisciplinary development projects. You will be the Regulatory Affairs (RA) point of contact for active medical devices and/or in vitro diagnostic medical devices. You will work with different disciplines and liaise with customers and other external parties.
Your responsibilities include safeguarding product safety and ensuring that working methods align with the quality system. You will identify applicable laws and regulations, coordinate these matters with the customer and prepare the technical file for certification.
What you bring
- A relevant university-level education in biomedical technology, technical medicine, health sciences or another technical field.
- At least two years of RA experience in the development and certification of active medical devices and/or in vitro diagnostic medical devices.
- Strong analytical skills and an understanding of engineering terminology.
- A team-oriented approach, good communication skills and the ability to work with people at different levels, including project teams and customers.
- An accurate, persuasive and pragmatic approach.
What is offered
- A good, market-rate salary.
- 31 days off and an 8% holiday allowance.
- A good pension scheme.
- Opportunities to attend training courses.
- A work laptop and phone.
- A bicycle scheme.
- An active staff association, social activities and annual sports events.
There is coffee and fresh fruit each week, as well as personal attention. Work-life balance is valued, and overtime is discouraged.