A growing MedTech is looking to expand their Regulatory team and are searching for a medical device expert for substance-based medical devices or non-active medical devices, you will focus on the regulatory and documentation support of medical devices across the entire product life cycle, e.g.:
- Development of tailor-made solutions and/or strategies for the approval of substance-based medical devices in accordance with MDR 2017/745
- Technical and regulatory processing of medical devices, ideally in combination with knowledge of pharmaceutical and/or cosmetic formulations
- Creation of technical documentation in accordance with Annex I/II/III of MDR 2017/745
Your profile:
- Completed training in the field of pharmaceutical or medical technology or a comparable educational background
- Sound knowledge and experience in writing technical documentation or CTD modules 3 and 2.3 in the context of pharmaceutical approvals
- In-depth knowledge and experience with the regulatory principles defined by the MDR (EU) 2017/745, especially for the regulation of substance-based medical devices
- Experience in the medical device industry, preferably in positions in research and development, regulatory/scientific affairs or at notified bodies
- Very good knowledge of German and English, both spoken and written
- Excellent project management skills
- High level of teamwork and communication skills
