BioTalent Ltd
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.
What You’ll Do
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
What We’re Looking For
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
Why This Role
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
#J-18808-Ljbffr
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.
What You’ll Do
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
What We’re Looking For
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
Why This Role
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
#J-18808-Ljbffr