Job opening
Regulatory Affairs Specialist
Filed under Staffing and Recruiting
Full job description
Job Description:
Position: Regulatory Affairs Specialist
Location: Orange County, CA (Hybrid)
Mode: Full-Time
Position Requirements:
- 6+ years of Regulatory Affairs experience within the medical device industry — medical device experience is required; pharmaceutical-only RA experience will not be considered.
- Experience with Class II and Class III medical devices.
- Ophthalmology/optometry experience is highly preferred, but strong medical device RA experience in other therapeutic areas will be considered.
- Strong experience with international regulatory submissions and registrations.
- Experience supporting regulatory activities across international markets, including :
- Canada
- EU/Europe
- India
- Japan
- Korea
- Australia
- China
- Experience preparing submissions, obtaining certificates from Operations, and supporting international RA affiliates.
- Experience with labeling and international labeling requirements.
- Experience supporting EU MDR activities.
- Experience with DHF remediation and providing broader regulatory support.
- International expansion/market-entry experience is highly desirable.
- Experience coordinating translations and working with external translation vendors is a plus.
- Additional language skills are preferred, particularly Spanish or Chinese.