Senior Regulatory Affairs Manager

Are you a Regulatory Affairs professional in the medical technology field, looking for a new opportunity?

 

Would you like to support the international market access of high-risk, complex medical devices?

 

We're currently supporting a client in the medical device industry who are located in Freiburg and looking to strengthen their team.

 

Key Responsibilities:

• Prepare and compile regulatory submissions for new medical device registrations and updates to existing products in compliance with regulations
• Oversee the successful approval of Class III medical devices for the European and US markets (MDR and FDA regulations)
• Monitor new legislation, policies, standards, and guidelines
• Perform post-market surveillance and report any adverse events or field safety corrective actions
• Overseeing engineering changes, product labelling, and promotional materials

 

Requirements:

• A degree in Biomedical Engineering, Life Sciences, or a related field
• At least 3-5 years of experience in regulatory affairs/international product approvals
• Comprehensive understanding of MDR/FDA requirements and associated guidelines
• Fluency in German and English

 

If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.