We have an exciting opportunity for a team lead to join the team The client is an established leader in the medical device market and operates globally.
Key Responsibilities:
- Manage the Regulatory Affairs department and oversee daily operations
- Demonstrate excellent understanding and of IVDR and IVD in relation to German regulations
- Provide management support for other regulatory products
- Implement new standards regarding regulations for the client's products
- Do coordination of products in accordance with regulatory affairs regionally
Key Requirements:
- BSc. Degree or higher in Life Sciences
- 5+ years experience within regulatory affairs- IVD and medical devices
- Excellent understanding of IVDR
- Ability to grasp new concepts quickly and to assimilate/evaluate scientific data
- Ability to work under pressure and to strict deadlines with attention to detail
- Ability to work independently and as part of a team in a matrix organisation
- Strong influencing/negotiation, written and oral communication skill
- Strong project management skills
