For our partner, a medical devices contract developer with focus on the field of orthopedic implants and instruments, we’re looking for a Regulatory Affairs Officer. The company provides services in innovation, Research & Development, Operations and act as Legal Manufacturer for over 15 Medical Devices.
The main focus as RA Officer is to support the Regulatory Strategies, lead submissions and provide guidance and follow-up for projects and customers. In this position you’ll report to the QA/RA Manager.
- You’re be actively involved in about three to five regulatory device submissions per year in the EU/US
- You’re part of the MDR project
- You’ll support the Regulatory strategies of the organisation
- You’ll lead submissions of devices
- You’ll give guidance in the follow-up of projects and customers
- Minimum of Bachelor working level
- At least two years’ experience within Regulatory Affairs for Medical Devices
- Knowledge of and experience with submissions under MDD/MDR/FDA is a preference
- Analytical, independent, result driven and customer focused
ORGANISATION AND OFER
You’ll join an entrepreneurial, growing, open and informal organisation and will be involved in successful projects with customers all over the world. You’re part of a multi-disciplinary team that is continuously creating value for their clients, medical professionals and patients. RA and QA are key within the company.
This is a unique opportunity to develop yourself and to grow within the company. You can expect an attractive salary and benefits.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org