Regulatory Affairs Officer

Location Netherlands
Discipline: Medical Device
Job type: Permanent
Contact name: Christian Steenkamp

Contact email:
Job ref: 11798
Published: 10 days ago
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
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