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).