ageneo Life Science Experts (Interim Solutions) GmbH

For an international medical device company, we are looking for an experienced Freelance Regulatory Affairs Manager to support the team during an interim phase. The role is operational and focuses on keeping ongoing regulatory activities on track across key international markets.

Tasks & responsibilities:

• Support and manage ongoing regulatory submissions and lifecycle activities
• Prepare and review technical documentation and submission dossiers
• Support FDA-related activities, including 510(k), De Novo or PMA documentation
• Coordinate MDR-related documentation and communication with the Notified Body
• Support international registrations, including China and other relevant markets
• Contribute to CER, PMCF, PMS, PSUR and vigilance activities in close collaboration with Clinical and Quality
• Prepare for audits, inspections and authority interactions
• Coordinate external partners, consultants and local agents where required
• Support regulatory intelligence and implementation of changing requirements

Professional requirements:

• Several years of operational Regulatory Affairs experience in the medical device industry
• Strong knowledge of FDA requirements and EU MDR
• Experience with higher-risk or Class III products is highly desirable
• Hands-on experience with international registrations is an advantage
• Independent, structured and pragmatic working style