Principal/Sr. 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 II or III medical devices.
SaMD experience required
Experience working with Class III devices.
Austin Vita is acting as an Employment Agency in relation to this vacancy.
Austin Vita is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.