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Job

Manager of Regulatory Affairs

  • Location

    San Francisco, CA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Cortland Hotz

  • Contact email:

    c.hotz@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2020-08-05

  • Startdate:

    ASAP

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).