Associate Director, Regulatory Affairs – In Vitro Diagnostics, Digital Health

Job Description:

  • Support device regulatory strategies across development, submissions, and commercialization
  • Coordinate regulatory pathways, development timelines, and commercialization plans
  • Lead health authority meetings covering In Vitro Diagnostics and Digital Health Technology
  • Present regulatory positions during agency interactions and discussions
  • Communicate critical program updates and regulatory risks to senior management
  • Build relationships with internal stakeholders and external device development partners
  • Monitor emerging technologies and global regulations impacting diagnostics and digital health

Requirements:

  • Bachelor’s degree in a scientific discipline
  • 8 years of pharmaceutical or medical device industry experience
  • 5+ years of Medical Device/In Vitro Diagnostics regulatory affairs experience
  • Experience with U.S. medical device submissions, including pre-submissions, Investigational Device Exemption (IDE), 510(k), and Premarket Approval (PMA)
  • Experience with international device regulations, including Medical Device Regulation/In Vitro Diagnostic Regulation (MDR/IVDR) and PMDA requirements
  • Knowledge of Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology regulations
  • Strong project management skills
  • Strong written and verbal communications skills
  • Ability to collaborate and influence

Benefits:

  • Annual bonuses or other incentive plans
  • Equity awards
  • Pension or retirement benefits
  • 401(k) company match
  • Health and wellness programs
  • Fitness centers
  • Medical, dental, vision, life and disability insurance benefits
  • Paid time off
  • Family support benefits
  • Reasonable accommodation for applicants with known disabilities or chronic illnesses
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