Remote Senior Device Regulatory Lead – Diagnostics

Regeneron Pharmaceuticals; United States; Remote; USD 180,000 - 293,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Senior Device Regulatory Affairs Lead, Diagnostics Focus to join our Regulatory Affairs team. This role leads regulatory strategies for Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology, collaborating with cross-functional partners in a remote work model.

You will drive submissions and health authority interactions, coordinate development timelines, and communicate regulatory risks to senior management as Regeneron advances its

Qualifications

• 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 (IDE, 510(k), PMA) and international MDR/IVDR/PMDA requirements.
• Knowledge of Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology regulations.

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 regulatory updates and 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.
• Thrive in a collaborative environment and drive regulatory excellence.

Skills

Regulatory strategy

Cross-functional collaboration

Project management

Regulatory affairs

US submissions

MDR/IVDR

Companion Diagnostics

In Vitro Diagnostics

Digital Health

Communication

Education

Bachelor's degree

Advanced degree preferred

Job description

Regeneron Pharmaceuticals is seeking a Senior Device Regulatory Affairs Lead, Diagnostics Focus to join our Regulatory Affairs team. This role leads regulatory strategies for Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology, collaborating with cross-functional partners in a remote work model.

You will drive submissions and health authority interactions, coordinate development timelines, and communicate regulatory risks to senior management as Regeneron advances its