Description
A growing global lifesciences company is seeking a Senior Regulatory Affairs Specialist to join their global regulatory affairs team located in the San Francisco Bay Area.Responsibilities:
- Serves as core team member for development teams, providing regulatory input and guidance.
- Develops regulatory strategies for new and existing in-vitro diagnostics products.
- Prepares and files submissions for class II in-vitro diagnostic products, including 510(K)'s and Technical Files
- Review and approve change orders
- Interact and negotiate with regulatory bodies
Qualifications:
- Bachelor's Degree
- Experience authoring 510(K) submissions
- 3+ Years Regulatory Affairs Experience