Right now, I’m looking for a RA/QA Manager Benelux for a leading Medical Device company specialised in among others Orthopedics, Traumatology, Wound Care and Sport Medicines. For more than 150 years, this organisation is on a mission every day to improve the quality of life of patients.
In this position you’ll manage the RA/QA team and ensure Regulatory Compliance with the Medical Devices in the Benelux. Next to that, be responsible for managing the Quality System for the distribution of the devices according to ISO13485.
- Being the representative for the Quality Management system for Belgium and Netherlands
- Regulatory Intelligence Strategy and Implementation
- Support ISO/ CE certifications
- Manage internal and external audits
- Participate as a Regulatory Affairs partner in the launch of new products
- Ensure distribution according to GDP guidelines for Medical Devices
- Coordinate the regulatory follow-up of custom medical devices
- Training of Benelux colleagues to Quality & Regulatory Processes to ensure compliance
- Minimum of five years’ experience in Medical Devices
- Minimum of a Master’s degree in Pharmacy or other relevant field. PhD in science is a plus
- MDD/ MDR experience is a must and knowledge of pharmaceuticals is preferred
- Proven auditing experience
- Interpersonal skills, Leadership skills, Organised, Autonomy, Committed and Team player
ORGANISATION AND OFFER
This company is a leader in sports medicine, orthopedics, traumatology and wound care and dedicated to serving patients. At the same time, they continue to actively build an environment where every individual can fulfil their potential and be proud ambassadors for the company, the customers and their patients.
The organisation offers a competitive salary and benefits.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or email@example.com