Senior Regulatory Affairs Specialist

📍 Southern California | Hybrid (1–2 days onsite in San Diego or Irvine)

Sponsorship Notice: This position does not offer visa sponsorship now or in the future. Candidates must be authorized to work in the United States without sponsorship.

We’re partnering with a growing, commercial-stage medical device company to hire a Senior Regulatory Affairs Specialist to support a portfolio of Class II, software-driven medical devices
. This is a hands‑on role with strong exposure to FDA 510(k) submissions
, post‑market activities, and cross‑functional product teams.

• Support FDA 510(k) submissions for new products and product changes, including software, hardware, and firmware updates
• Contribute to regulatory strategy and lifecycle management for Class II devices
• Collaborate closely with R&D, Quality, Clinical, Product, and Marketing teams
• Review and approve marketing, labeling, and promotional materials for regulatory compliance (this is a key focus area)
• Support IDE and IND activities as part of a combination product and development‑stage environment
• Provide regulatory support for ongoing clinical studies and post‑market activities
• Monitor evolving FDA guidance related to software‑based devices, SaMD, and digital health

• 5+ years of Medical Device Regulatory Affairs experience
• Strong hands‑on experience supporting FDA 510(k) submissions (required)
• Familiarity with IDE and IND pathways (nice to have)
• Experience reviewing advertising and promotional materials
• Background with software‑driven or digital health medical devices strongly preferred
• Experience in diabetes devices, insulin pumps, or connected systems is a plus
• Comfortable operating in a fast‑paced, high‑change environment with minimal RA onboarding

• Work on impactful, patient‑facing medical technology
• High visibility within a lean, experienced regulatory team
• Exposure to advanced software‑enabled and algorithm‑driven devices
• Competitive compensation, bonus, and flexible PTO