Senior Device Regulatory Lead, Diagnostics (Remote)

Regeneron Pharmaceuticals, Inc (USA); United States; A distancia; USD 180.000 - 293.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, V

Paid time off

Family support benefits

Descripción de la vacante

Regeneron Pharmaceuticals, Inc is seeking a Senior Device Regulatory Affairs Lead, Diagnostics Focus to join Regulatory Affairs in a remote work model. The role supports device regulatory strategies across development, submissions, and commercialization, with emphasis on U.S.

IDE/510(k)/PMA submissions and international MDR/IVDR compliance. You will lead health authority meetings, communicate regulatory risks to leadership, and collaborate with internal and external partners to advance

Formación

• 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 (pre-submissions, IDE, 510(k), PMA).
• Experience with MDR/IVDR and PMDA international device regulations.
• Knowledge of Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology regulations.
• Strong project management skills and regulatory leadership.

Responsabilidades

• 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.

Conocimientos

Regulatory strategy

Project management

Written communication

Verbal communication

Collaboration/influence

FDA submissions

Educación

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Descripción del empleo

Regeneron Pharmaceuticals, Inc is seeking a Senior Device Regulatory Affairs Lead, Diagnostics Focus to join Regulatory Affairs in a remote work model. The role supports device regulatory strategies across development, submissions, and commercialization, with emphasis on U.S.

IDE/510(k)/PMA submissions and international MDR/IVDR compliance. You will lead health authority meetings, communicate regulatory risks to leadership, and collaborate with internal and external partners to advance