Our client is a global manufacturer of respiratory devices and currently have an important focus on 510k submissions in collaboration with American colleagues, plus the EU MDR.
On a part-time basis, they are looking for a Regulatory Affairs Specialist to be responsible for technical documentation for class IIa MDR medical devices in cooperation with the R&D team. You will also support our local teams worldwide with country-specific product registration.
• Preparation and maintenance of the EU MDR Technical Documentation for product registration
• Support of the development department in documentation and regulatory issues
• Regulatory support for the development department (design projects, design changes)
• Monitoring of (inter) national regulations and changes in legislation
• Support in post-market surveillance according to MDD / EU MDR and other international regulations
• Bachelor in Engineering or science or any other relevant discipline
• 2+ years of practical experience in medical technology and regulatory affairs
• Experience in the approval of medical devices with in-depth knowledge in the area of ??MDD / EU MDR
• Very good knowledge of German and English
To discuss this role and further opportunities in Regulatory Affairs, please contact Rebecca Stevens at Rebecca.Stevens@adaptivelifescience.com