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Sr. Regulatory Affairs Specialist

Company Name: OrthAlign, Inc.
Location: Aliso Viejo, CA
Job Type: Regulatory Affairs
Contact Name: David Vancelette
Phone: (949) 525-9034
Fax: (949) 831-9500
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: TBD

Job Description

OrthAlign, Inc. is a small, fast growing medical device company in an exciting new area of orthopedics. We are bringing advanced navigation technology to surgeons, in a simple handheld device. Opportunities abound for capable and motivated individuals. Make your next career move with us!

The Sr. Regulatory Affairs Specialist is responsible for supporting the regulatory requirements for OrthAlign’s product registrations and distribution, both in the US and internationally. The Sr. Specialist shall ensure OrthAlign’s internal documents and agency filings are in compliance with applicable regulations and company SOPs.

Job Requirements

RA Experience in: > 5+ years medical devices. > 510k Class II clearance. > CE Mark (Class Ims, IIa minimum). MDD, MEDDEVs. > International RA (Latin America, IRAMEA or other). > FDA guidance, export document reqs, MDRs. > Labeling review. > Translations (management).