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Permanent

Principal/Sr. Regulatory Affairs Specialist (Class III)

  • Salary

    US$140000.00 - US$160000.00 per year + Bonus + Equity (Salary Negotiable)

  • Sector

    Compliance

  • Job Ref

    27113

  • Contact

    Daniel Boyce

  • Published

    13 days ago

Daniel Boyce
Daniel Boyce
Technical Recruiter

Overview

Principal/Senior Regulatory Affairs Specialist CA-Redwood City

Role

Principal/Senior Regulatory Affairs Specialist

*Remote*

About

We are looking for a strong Principal, or Senior depending on experience, Regulatory Affairs Specialist that can help seek global registrations and approvals for a new Class III electromechanical medical device.

Minimum

  • 3-4 years of regulatory affairs experience within medical devices.

  • Working knowledge of the Quality System Regulation 21 C.F.R. 820, ISO:13485:2016 and international regulations for medical devices (including: EU, Canada, Brazil, Australia, and Japan).

  • Experience working with Class III medical devices.

Preferred

  • Experience working with devices that incorporate software or experience with software as a medical device (SaMD).

Benefits

  • Competitive Salary

  • Equity

  • Bonus

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