For a dynamic globally operating Medical Device organisation I’m looking for a Sr. RA/QA Specialist. This highly innovative company is continuously developing new technologies and products and at this moment a third manufacturing is being built.
In this position, you’ll be active with worldwide regulatory submissions for medical device registration. You’ll interact with other departments throughout the process and also take part in Quality related topics.
- Compile and prepare regulatory submissions for medical device registration in accordance with GMP, ICH Q7, ISO 13485, MDR 2017/745, ISO 14971 and related country regulations;
- Assure regulatory compliance from the start of design and development up to and after release of the product to the market;
- Next to regulatory, you’re partially active with managing the Quality System, ISO and auditing.
- Training of coworkers;
- You will align and discuss the regulatory strategy with the headquarters.
- Minimum of a Bachelor’s Degree in Chemistry, Biochemistry, Life Sciences or comparable. Master’s degree is a plus;
- 4-5 years’ experience in Regulatory Affairs in a medical device or pharmaceutical company;
- Knowledge and understanding of European and US regulations for medical devices. ISO 13485 is a must. ISO 14971, ICH guidelines, GMP and other relevant guidelines are a plus;
- Experience or knowledge related to clinical investigations for medical devices is considered a pre;
- Willingness to travel abroad. Expected frequency up to 4 times a year;
- The function is possible for 32 hours a week.
ORGANISATION & OFFER
The organisation is developing a biomedical device. Everyone is highy valued within the company. The employees are they key to success and they want that the company feels like home.
In case of compensation and benefits, the organisation a very generous package, which among others contents an attractive salary and bonus scheme, good training and opportunities, flexible working hours, excellent pensioen regulation and other secondary working conditions.
INTERESTED? Please contact for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org