Manager Regulatory Affairs Operations | Manager (m/w/d)
Unknown Employer
Job Summary
As the Manager Regulatory Affairs Operations, you will play a crucial, cross-functional role in shaping the future of healthcare by ensuring timely product implementation and conformity across the product lifecycle within an international environment. Day-to-day tasks involve collaborating globally with R&D, QA, Manufacturing, and Marketing teams, managing product portfolios, and optimizing IT infrastructure related to regulatory documentation. You will also provide strategic and technical consulting on regulatory issues, focusing on risk management, labeling, and post-market surveillance. Key requirements include a university degree in a scientific or technical field, coupled with professional experience in the medical device sector and proven expertise in MDR and ISO 13485. This challenging position offers the chance to actively contribute to product quality and regulatory compliance, making it attractive for professionals seeking impact in a global healthcare setting who are fluent in both German and English.
Required Skills
Education
University degree in science or technical sciences or an equivalent qualification
Experience
- Professional experience in the medical device environment or another regulatory field of work
- Proven experience with MDR (Medical Device Regulation)
- Proven experience with ISO 13485
- Knowledge or experience in medical devices, technical documentation, and regulatory product documentation
- Knowledge or experience in conformity assessment and post-market surveillance
- Knowledge or experience in electronic regulatory document control and management systems
Languages
Additional
- Not specified