Job Details

Overview

Regulatory Affairs Staff Specialist

Location : San Diego, CA (Onsite)

Salary Range : $120,000 - $147,000

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

• Bachelor's degree in Life Sciences, Engineering, or related field (Advanced degree preferred).
• 6+ years in Regulatory Affairs, with 4+ years in IVD Regulatory Affairs.
• Experience with 510(k) submissions, IVDR compliance, and global registrations.
• Strong knowledge of IVD regulations, ISO 13485, QSR, and international standards.
• Excellent written and verbal communication skills for regulatory documentation and agency interactions.
• Ability to manage multiple projects in a fast-paced environment.

Work Environment & Travel

• Onsite in San Diego, CA.
• Limited travel.