Principal/Senior Regulatory Affairs Specialist CA-Redwood City
Principal/Senior Regulatory Affairs Specialist
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.
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.
Experience working with devices that incorporate software or experience with software as a medical device (SaMD).