Head of Regulatory Affairs (m / f / d) Combination Products
As a Head of Regulatory Affairs (m/f/d) you'll take ownership of all Regulatory topics in a very critical role to the company's future and help to fulfil relevant national and international regulatory requirements. A great opportunity to join a leading Medical Device company in Germany with a great portfolio of products .
Your Responsibilities Will Include, But Are Not Limited To:
- Coordination and implementation of the approval of our products for international markets
- Creation of regulatory strategies and plans for worldwide approvals
- Independent preparation of the submission documentation for the global approval of medical devices
- Creation of all required registration documents and procurement of the necessary certifications in exchange with external interfaces
- Preparation, organisation and support of audits by notified bodies and authorities
- Contact person (m / f / d) for regulatory issues
- continuously drive the optimisation of global, cross-location regulatory affairs processes
Key Requirements:
- Bachelor of Science degree in engineering or a scientific/technical discipline
- A minimum of 7 years related experience in the medical device industry in Regulatory Affairs, with at least 3 years of experience in leadership
- 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) and FDA
- Experience working with drug-delivery products and combination products
- Support with international registrations
- Knowledge and experience with Software as a Medical Devices (SamD)
- Demonstrated ability to work constructively across all functions of the organisation
- Very good written and spoken German and English
