Senior Regulatory Affairs Manager for Medical Devices | Biologe (m/w/d)
Sutter Medizintechnik GmbH
Job Summary
As a Senior Regulatory Affairs Manager, you will play a pivotal role in ensuring market access for innovative medical devices. Working within a modern, owner-managed company of 200 employees, you will be responsible for the creation, maintenance, and approval of technical documentation in accordance with the Medical Device Regulation (MDR) for product classes I to IIb. Your daily activities include conducting clinical evaluations, performing literature research, and managing country-specific registrations globally. You will serve as a key technical contact for regulatory compliance, communicating directly with authorities, notified bodies, and international partners. This role is ideal for a professional who thrives in a hands-on industrial environment and values precision and quality. The position is primarily based on-site to foster team collaboration, though flexible working arrangements and home office options are available. You will contribute to a mission-driven company that holds over 35 patents and operates a global distribution network, ensuring clinical outcomes are improved worldwide.
Required Skills
Education
Completed university degree in a technical or scientific field of study.
Experience
- Minimum 5 years of professional experience in Regulatory Affairs within a hands-on industrial medical device environment
- Extensive experience in creating and maintaining technical documentation according to MDR
- Proven track record in clinical evaluation and literature research
- Experience in international approvals and communication with notified bodies
- Professional experience in quality management systems and regulatory compliance
Languages
Additional
- The role is primarily based at the company headquarters to facilitate team interaction, with home office available by individual arrangement. Candidates must have the ability to assess complex regulatory issues and prioritize tasks within a team setting.