Senior Manager Regulatory Affairs - Biophase : Job Details

12 hours ago Be among the first 25 applicants

This range is provided by BioPhase. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$130,000.00/yr - $190,000.00/yr

Direct message the job poster from BioPhase

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Life Sciences community. We are currently looking for an ONSITE Sr./Regulatory Affairs Manager for a leading San Diego area medical device/diagnostic company.

*Must be willing to relocate and work fully onsite in San Diego, CA.

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 (