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

Regeneron

. Support device regulatory strategies across development, submissions, and commercialization .

Posted 11/3/2026full-timeRemote • United StatesSenior💰 $179,600 - $293,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategies for Medical Devices and In Vitro Diagnostics, with a strong focus on U.S. submissions and international regulations. Proven ability to manage projects, communicate effectively, and build relationships with stakeholders in the pharmaceutical and medical device industries.

Highest-signal resume keywords

Medical Device Regulatory AffairsIn Vitro Diagnostics ExperienceU.S. Medical Device SubmissionsProject Management SkillsStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategiesMedical Device SubmissionsInvestigational Device Exemption (IDE)510(k)Premarket Approval (PMA)Medical Device Regulation (MDR)In Vitro Diagnostic Regulation (IVDR)Companion Diagnostics KnowledgeDigital Health Technology Regulations

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationCollaborationInfluencing Skills

Industry Keywords

Pharmaceutical IndustryMedical Device IndustryDiagnosticsDigital HealthHealth Authority Meetings

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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