Develop global regulatory approval strategies for medical devices in the areas of anesthesia, intensive care, and thermal therapy
Lead a Regulatory Affairs team of 13
Ensure market access and regulatory compliance
Take responsibility for parts of global approval and re-registration strategies
Provide proactive regulatory advice and support in interactions with authorities

Degree in engineering, natural sciences, or a comparable qualification
Several years of professional experience and ideally prior leadership experience in an internationally oriented Regulatory Affairs role
Solid, up-to-date knowledge of international regulatory requirements, product liability, and relevant medical device standards/regulations (e.g., ISO 13485, ISO 14971, 21 CFR Part 820, MDR)
Strong experience with regulatory software and databases, and business-fluent English skills

Regulatory Affairs Team Leader

Key skills