What are the responsibilities and job description for the Regulatory Affairs Staff Specialist position at BioPhase Solutions?
Job Description
Job Description
Regulatory Affairs Staff Specialist
Location : San Diego, CA (Onsite)
Salary Range : $120,000 - $147,000
Job Summary
BioPhase is seeking a Regulatory Affairs Staff Specialist to support regulatory compliance and product registrations for in vitro diagnostic (IVD) products. This role will lead regulatory submissions, assess product changes, and ensure compliance with FDA, EU IVDR, and global regulatory requirements. The ideal candidate will collaborate cross-functionally to drive regulatory excellence.
Responsibilities
- Prepare and submit 510(k), IVDR Technical Documentation, and other regulatory submissions.
- Conduct regulatory assessments for product changes and compliance.
- Collaborate with R&D, Quality, Manufacturing, and Marketing teams.
- Monitor global regulatory trends and assess their impact on product compliance.
- Review and approve product labeling, advertising, and promotional materials.
- Maintain regulatory documentation and support market authorizations.
- Assist with regulatory inspections, audits, and compliance initiatives.
Qualifications
Work Environment & Travel
Salary : $120,000 - $147,000
