Title: Regulatory Affairs Project Manager
Summary: A globally established, innovative leader in the medical device industry is looking for a dynamic regulatory professional to come join their team as a Regulatory Affairs Manager. This world renowned company is looking for a regulatory leader to play a key role in the project management of various regulatory activities, acting as an expert regulatory resource for diagnostic products and global health authority interactions.
The Regulatory Affairs Manager will be responsible for:
- Developing, implementing, and managing new regulatory policies, procedures and SOPs
- Provide regulatory expertise for the end-to-end lifecycle of a product, specifically IVD and IVDR products
- Build and mentor a team of junior regulatory professionals
- Interacting and negotiating directly with global health authorities throughout the submission process
The Regulatory Affairs Manager should have the following qualifications:
- Bachelor's degree in science required.
- 5+ years of experience in Regulatory Affairs, 2 years of managerial experience preferred
- Direct experience FDA submissions within the med device industry, including 510Ks
- Experience working with Diagnostic products, such as IVD/IVDR
If you are interested in the Manager, Regulatory Affairs role, then please don't wait to apply.
