Head of Regulatory Affairs (m / f / d) Medical Devices
One of our key clients in Germany is looking to fill in a Head of Regulatory Affairs position for the German market who is eager to take on a new challenge. You will join a large, complex, matrix organization reporting to the European Head of Regulatory Affairs of Medical Devices.
Your Responsibilities Will Include, But Are Not Limited To:
- You will report directly to the Director of Regulatory Affairs and are particularly responsible for international approvals.
- You will be responsible for a team.
- You confidently maintain contact with registration authorities and country representatives, draw up regulatory contract content and advise colleagues on the right approval strategy.
- You will create and maintain technical documentation and will also be responsible for checking and approving packaging and advertising materials.
- Representation of the Regulatory Affairs department in audits by authorities and notified bodies for the area of responsibility
- You lead cross-functional and cross-organizational topics and teams to build and maintain global processes and relationships.
- Bachelor of Science degree in engineering or a scientific/technical discipline
- 10+ years related experience in the medical device, with at least 5 years of experience in Regulatory Affairs
- Strong knowledge of the normative and regulatory requirements for medical devices (ISO 13485: 2016, ISO 14971: 2019, Directive 93/42 / EEC and Regulation (EU) 2017/745 (MDR)
- Excellent ability to work in a team and enjoy working with internal interfaces
- Demonstrated ability to work constructively across all functions of the organization
- Native German and Fluent English