Regulatory Affairs Manager

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

• Bachelor’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.
• Limited travel (

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Regulatory Manager • San Diego, CA, US

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