CAREERS · VENTURE COVERAGE Albright Laboratories is an equal opportunity employer. View all open roles.
Venture Coverage

Regulatory Affairs Analyst (FDA / HIPAA)

Level: Mid-Senior Department: Ventures Location: Florida HQ / Remote-OK Classification: W-2

Mission

Own regulatory analysis for Albright's Medicine venture coverage — FDA software guidance, HIPAA, state medical-board requirements, and the diligence that lets Albright partner credibly in regulated healthcare.

Responsibilities

  • Track FDA software, AI/ML, and SaMD guidance
  • Author regulatory diligence memos on venture targets
  • Advise engineering on regulatory implications of architecture decisions
  • Partner with General Counsel on healthcare compliance posture
  • Maintain regulatory-landscape briefings for the executive team
  • Support proposal authorship on healthcare-vertical federal pursuits
  • Build relationships with regulatory professionals and FDA-experienced counsel

Required qualifications

  • 4+ years regulatory affairs in software or medical devices
  • Working knowledge of FDA software guidance and 510(k) pathway
  • Strong HIPAA expertise
  • Demonstrated regulatory-writing track record

Preferred qualifications

  • RAC (Regulatory Affairs Certification)
  • Background at a digital-health or medical-device company
  • Experience with EU MDR or international regulatory frameworks
  • Florida base
Albright Laboratories is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic. Compensation bands reflect published US benchmarks at the cited source and may be adjusted for experience, location, and total compensation mix. Federal-Cleared roles require US citizenship and an active or eligible security clearance per the role description.