MDR + RA Manager | middle sized company
Our client is an innovative and owner-managed family business that was founded in the early 2000s. As an international manufacturer, they develop, produce and sell high-quality medical products.
As Regulatory Affairs Manager for the Medical Devices division of our client, you will be responsible for regulatory monitoring and proactive support in ensuring compliance with regulatory requirements (MDD/MDR/FDA). You are part of a motivated team that wants to win new countries with exciting and innovative products.
- Ensuring compliance with regulatory requirements (MDD/MDR/FDA) in cooperation with the development departments in the product development process
- Checking the regulatory documents of third-party products (e.g. MDR, Article 13(2) and 14(2))
- Development of registration strategies for medical devices
- Regulatory support of systems according to Art. 22 MDR
- Regulatory support of parts and components according to Art. 23 MDR