Job Title: Regulatory Affairs Specialist
Location: Carlsbad, CA
Pay Range: $35.00/hr - $36.00/hr (based on skills and experience)
Shift: M-F, Business Hours (Hybrid schedule: 3 days on-site / 2 days remote)
Duration: 4 months+
Qualifications:
- 2–4 years of Regulatory Affairs experience supporting international markets
- Strong knowledge of international medical device regulations
- Ability to work independently, manage multiple submissions, and adapt quickly
- Excellent organizational and communication skills for global teamwork
Responsibilities:
- Support international regulatory submissions and renewals for markets including Mexico, Colombia, Saudi Arabia, Chile, and Japan
- Coordinate with international consultants and distributors to gather requirements, prepare documentation, and submit registration files
- Collaborate with Marketing and Engineering teams on product changes, line extensions, and compliance
- Track ongoing projects and ensure timely regulatory filings
- Serve as the main contact for distributor requests and manage communications proactively
Additional Details:
- Seniority Level: Associate
- Employment Type: Temporary
- Job Functions: Quality Assurance, Manufacturing, Engineering
- Industry: Medical Equipment Manufacturing
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