Regulatory Lead, Diagnostics & Digital Health (Remote)

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 180,000 - 260,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director of Regulatory Affairs focused on In Vitro Diagnostics and Digital Health, with strategic leadership across companion diagnostics and device programs.

This remote role collaborates with cross-functional teams and external partners to navigate regulatory submissions and health authority interactions. Ideal candidates bring 8+ years in pharma or device regulatory affairs, deep knowledge of US submissions (IDE/510(k)/PMA) and MDR/IVDR,

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• 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 (IDE, 510(k), PMA) and global regulations (MDR/IVDR).
• Strong written and verbal communication skills; ability to influence cross-functionally.

Responsibilities

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

Skills

Regulatory strategy

Medical device regulations

US 510(k) IDE PMA

Cross-functional collaboration

Regulatory submissions

Written communication

Verbal communication

Stakeholder management

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Job description

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director of Regulatory Affairs focused on In Vitro Diagnostics and Digital Health, with strategic leadership across companion diagnostics and device programs.

This remote role collaborates with cross-functional teams and external partners to navigate regulatory submissions and health authority interactions. Ideal candidates bring 8+ years in pharma or device regulatory affairs, deep knowledge of US submissions (IDE/510(k)/PMA) and MDR/IVDR,