Global Regulatory Affairs Lead - Medical Devices

BD; Franklin Lakes (NJ); Presencial; USD 110.000 - 176.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Flexible Spending Accounts

Dental coverage

Vision coverage

Life and AD&D insurance

Descripción de la vacante

BD is seeking a Senior International Regulatory Affairs Specialist to partner in preparing and approving regulatory submissions for medical devices worldwide. The role requires leading regulatory requirements analysis, developing strategies, and coordinating with cross-functional teams to ensure timely registrations and lifecycle management.

The candidate will navigate DHF/STED documents, manage risks, and drive regulatory programs across multiple regions to support market access goals.

Formación

• Bachelor’s degree or higher in health/science related field.
• 6+ years in the medical device regulatory field.
• Experience with international regulatory registrations across multiple regions.
• Familiarity with STED/technical files and submission content.
• Experience with SAP, MasterControl, JDE and Microsoft tools.

Responsabilidades

• Lead collecting, compiling, and analyzing country-specific regulatory requirements.
• Drive international registrations according to project plan.
• Prepare and compile information for regulatory submissions and submissions responses.
• Collaborate with cross-functional teams for data requests and regulatory needs.
• Develop regulatory strategies for product registrations, renewals, and lifecycle changes.
• Identify regulatory risks and mitigate impacts to support timelines.
• Coordinate with quality systems and regulatory processes across regions.
• Support global product lifecycle activities and labeling updates.

Conocimientos

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Risk assessment

Regulatory knowledge

Educación

Bachelor’s degree in health science, life science, biology, chemistry, bio-engineering, microbiology, or a related field

Herramientas

SAP

MasterControl

JDE

Microsoft Office

Descripción del empleo

BD is seeking a Senior International Regulatory Affairs Specialist to partner in preparing and approving regulatory submissions for medical devices worldwide. The role requires leading regulatory requirements analysis, developing strategies, and coordinating with cross-functional teams to ensure timely registrations and lifecycle management.

The candidate will navigate DHF/STED documents, manage risks, and drive regulatory programs across multiple regions to support market access goals.