Global Regulatory Strategy Lead – Labeling & eIFU

Becton, Dickinson and Company; Franklin Lakes (NJ); On-site; USD 138,000 - 220,000; Full time

Benefits offered by this job

Annual Bonus Potential

Discretionary LTI Bonus

Health and Well-being Benefits

Medical coverage

BD 401(k) Plan

Educational assistance

Paid time off

Job summary

Becton, Dickinson and Company (BD) is looking for a Regulatory Affairs Strategist, Globalization to shape worldwide regulatory strategies related to labeling, eIFU, registrations and device listings. You will partner with Business Units, Regions and Central RA to drive standardized, scalable processes and compliance excellence.

The role requires strong technical expertise in labeling, eIFU and registrations, plus significant regulatory experience in the medical device sector.

Qualifications

• Bachelor's degree in science, engineering, or technology discipline.
• Minimum 8 years of experience in the medical device industry, with at least 5 years in Regulatory Affairs.
• Master’s degree in business, management, or technology related field preferred.
• Regulatory Affairs Certification (RAC) desirable.

Responsibilities

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

Skills

Regulatory affairs

Labeling

eIFU

Establishment registrations

Device listings

Stakeholder collaboration

Risk mitigation

Regulatory strategy

Regulatory governance

Communication

Education

Bachelor's degree in science/engineering/technology

Master's degree in business/management/technology

Regulatory Affairs Certification (RAC)

Job description

Becton, Dickinson and Company (BD) is looking for a Regulatory Affairs Strategist, Globalization to shape worldwide regulatory strategies related to labeling, eIFU, registrations and device listings. You will partner with Business Units, Regions and Central RA to drive standardized, scalable processes and compliance excellence.

The role requires strong technical expertise in labeling, eIFU and registrations, plus significant regulatory experience in the medical device sector.