Associate Director, Regulatory Affairs - In Vitro Diagnostics and Digital Health

Regeneron Pharmaceuticals

7d • $179,600 - $293,000 • Remote

About The Position

Regeneron is seeking a regulatory affairs leader to support device and diagnostics programs. The role focuses on leading regulatory strategies for Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology across development, submissions, and commercialization. It involves coordinating regulatory pathways, development timelines, and commercialization plans; leading health authority meetings; presenting regulatory positions in agency interactions; and communicating program updates and risks to senior management. The position also involves building relationships with internal stakeholders and external device development partners, and monitoring emerging technologies and global regulations that affect diagnostics and digital health. The posting describes the work model as remote and lists a Monday–Friday schedule.

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 communication skills.
• Ability to collaborate and influence.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• 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.

Benefits

• Annual bonuses or other incentive plans, depending on country and role.
• Equity awards, depending on country and role.
• Pension or retirement benefits, depending on country and role.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits, including medical, dental, vision, life, and disability insurance.
• Paid time off.
• Family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director