Regulatory Affairs Manager
BioPhase SolutionsSan Diego, CA, US2 days ago
Salary
$145,000.00–$165,000.00 yearly
Job type
- Full-time
Job descriptionBachelor’s degree in Bioengineering, Biochemistry, Molecular Biology, or related field (Advanced degree preferred). 8+ years in Regulatory Affairs, with 5+ years in IVD regulatory roles. Experience securing approvals in US, EU IVDR, Canada, Australia, etc. Strong leadership and cross-functional collaboration skills. Proficiency in regulatory submission tools and Microsoft Office Suite. Onsite in San Diego, CA. Limited travel (
Job Description
Job Description
Regulatory Affairs Manager
Location : San Diego, CA (Onsite)
Salary Range : $145,000 - $165,000
Job Summary
BioPhase is seeking a Regulatory Affairs Manager to lead regulatory strategy and compliance for in vitro diagnostic (IVD) products. This role oversees regulatory submissions, market authorizations, and agency communications, ensuring compliance with FDA, EU IVDR, and global regulations. The ideal candidate will collaborate cross-functionally and drive regulatory excellence.
Responsibilities
- Develop and execute global regulatory strategies for IVD products.
- Lead preparation of 510(k), IVDR Technical Documentation, and other regulatory submissions.
- Manage regulatory assessments for product changes and compliance.
- Collaborate with R&D, Quality, Manufacturing, and Marketing teams.
- Mentor and lead a team of regulatory professionals.
- Monitor global regulatory trends and implement best practices.
- Support regulatory inspections and audits.
Qualifications
Work Environment & Travel