Senior Regulatory Affairs Manager (m/f/d) - Medical Devices
Salary: Competitive
Location: Munich, Germany
A leading medical equipment manufacturing company based in Hamburg, Germany is seeking a Senior Regulatory Affairs Manager. You will join a large, complex, matrix organisation reporting to the Director of Regulatory Affairs of Medical Devices.
The Head of Regulatory Affairs will do the following:
- You will report directly to the Director of Regulatory Affairs and are particularly responsible for international approvals.
- Leading and managing the requirements for the medical device portfolio
- Overseeing quality management systems (including coordinating support and control of all plans)
- Representation of the Regulatory Affairs department in audits by authorities and notified bodies for the area of responsibility
- Coordinating vigilance activities and associating with notified bodies
- Processing the approval and certification of products
- Must help to create risk file and technical documentation
- Coaching and training others in quality methods
Requirements:
- An academic degree within a technical field such as engineering
- 5+ years of experience within quality and regulatory affairs in Medical Technology dealing with regulations for medical devices (including ISO 13485, MDD 93/42 EWG, 21CFR 820; MDR 2017/745)
- Experience regarding registration and approval of medical devices
- Applicants must be eligible to work in Germany
- Business fluent English, both written and spoken, good knowledge of German
- Positive attitude with ability to think in methodical and analytical manner