San Francisco, CA
5 months ago
Class 3 Medical Device Company!
Prepares Regulatory documentation in for product approval in US and International markets.
Support Regulatory risk identification and reduction strategy for pre- and post-market products.
This role with include components of Quality Compliance, QSR/GMP support, vigilance and post-market surveillance activities.
Communicate with International Distributors.
Work cross functionally between internal departments and external consultants to support Regulatory submissions - primary internal expert on preclinical testing of products.
Manages Company’s Explant/Retrieval Analysis program.
Responsible for educating internal team members.
Manages Company’s (PMCF) and (CER).