Regulatory Affairs Manager
We are looking for a seasoned Regulatory Affairs professional to drive our global product approval and compliance strategy.
Kurz:
- Develop regulatory strategies for new and existing products
- Establish and maintain PMS/PMCF data collection
- Collaborate closely with internal departments to ensure regulatory compliance
Herausforderungen des Jobs:
- Monitor and analyze regulatory requirements
- Assess their impact on the company
- Perform administrative tasks in Regulatory Affairs and ensure adherence to QM-Systems in daily work
Ideen sind willkommen:
- Bachelor's or Master's degree in Medical Technology or comparable field
- At least 5 years of experience in Regulatory Affairs or comparable roles
- In-depth knowledge of national and international regulatory requirements and guidelines (e.g. FDA, MDR)
- Analytical thinking and structured approach
- Excellent communication and negotiation skills in German and English