Global Regulatory Strategy Lead, Labeling & eIFU

Becton Dickinson NA; Franklin Lakes (NJ); Presencial; USD 138.000 - 220.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual Bonus

Discretionary LTI Bonus

Medical coverage

Health Savings Accounts

Flexible Spending Accounts

Dental coverage

Vision coverage

Life and AD&D insurance

Short-term disability

Long-term disability

Long-term care with life insurance

Paid time off

Descripción de la vacante

BD in New Jersey is seeking a Regulatory Affairs Strategist, Globalization to align and execute worldwide regulatory strategies and practices across BU, Regional and Central teams. The role requires expertise in labeling, eIFU, establishment registrations, and device listings with a focus on global regulatory excellence.

You will partner with Business Units and Regional Regulatory leaders to drive standardized processes, ensuring flexible, compliant solutions for local needs while maintaining

Formación

• Bachelor's degree in science, engineering, or technology required.
• Minimum 8 years of experience in the medical device industry, with at least 5 years in Regulatory Affairs.
• Strong knowledge of labeling, eIFU, establishment registrations, and device listings.
• Global regulatory experience across BU, Regional and Central teams.

Responsabilidades

• Provide centralized regulatory governance related global labeling requirements and information management, including eIFU.
• Develop, own and standardize labeling, eIFU, establishment registration and device listing processes.
• Act as a strategic partner to Business Units and Regional Regulatory leaders.
• Coordinate across Business Units, Regions, Central RA, and other functions.
• Harmonize key processes, and build communications channels across RA.
• Assist with risk mitigation plans and solutions.
• Stay apprised of global regulatory policy topics.

Conocimientos

Regulatory labeling

eIFU knowledge

Establishment registrations

Device listings

Global regulatory strategy

Cross-functional collaboration

Educación

Bachelor's degree in science/engineering/technology

Descripción del empleo

BD in New Jersey is seeking a Regulatory Affairs Strategist, Globalization to align and execute worldwide regulatory strategies and practices across BU, Regional and Central teams. The role requires expertise in labeling, eIFU, establishment registrations, and device listings with a focus on global regulatory excellence.

You will partner with Business Units and Regional Regulatory leaders to drive standardized processes, ensuring flexible, compliant solutions for local needs while maintaining