One of the leading Medical Device Manufacturer based in the north of Germany - offers innovative systems solutions for professional target groups in the medical sector focusing on (Class I - III) devices.
- Responsible for their national and international new registrations- for the entire process, developing an approval strategy to the associated documentation
- You will be the first contact for their national and international partners
- Professionally lead a team of regulatory managers
- Taking part in strategic direction of the team and the design of efficient processes as well as the Introducing new methods and tools
- Coordinating communication between Regulatory Affairs and Development plus Product Management departments.
- Implementing and ensuring compliance with current regulatory requirements between cross functions.
Requirements:
- Completed studies with a technical or scientific focus
- Several years as a regulatory affairs manager in the field of medical technology in the international Context
- If possible with first management experience - Leadership
- Standard and specialist knowledge in medical technology such as: ISO 13485, ISO 14971, 21 CFR part 820, MPG, MDR, product liability, international approval requirements
- Fluent English and German (C1/C2)
