Job Description

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.

Work Environment & Travel

Onsite in San Diego, CA.
Limited travel (<10%).

What we offer:

As we work to develop innovations that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

· Full support and career-development resources to help you reach your potential

· A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Apply now and let's make work better!

Job Tags

Work at office, Relocation,

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