Global Regulatory Strategy Architect (US/EU)

BD; Franklin Lakes (NJ); Sur place; USD 137 500 - 220 100; Plein temps

Avantages offerts par ce poste

Annual Bonus

Discretionary LTI Bonus

Medical coverage

Health Savings Accounts

Dental coverage

Vision coverage

Résumé du poste

BD is seeking a Regulatory Affairs Strategist, Globalization, to lead worldwide regulatory strategies for assigned areas. You will partner with Business Units and Regional leaders to enable compliant growth and market access through standardized processes.

The role requires a strong RA background with 8+ years in medical devices and 5+ years in regulatory affairs; RAC and a Master’s degree are a plus. On‑site collaboration is emphasized.

Qualifications

• Bachelor’s degree in science, engineering, or technology discipline required.
• 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) preferred.

Responsabilités

• Provide centralized regulatory governance related to the registration assessment process.
• Interpret global regulatory requirements to enable compliant growth and market access.
• Develop and standardize global regulatory registration assessments for cross‑regional use.
• Coordinate across Business Units, Regions, Central RA on eIPRRA processes.
• Harmonize key RA processes and build cross‑functional communication channels.
• Stay apprised of global regulatory policy topics.

Connaissances

Regulatory affairs

Strategic partnering

Regulatory policy

Communication

Cross-functional collaboration

Formation

Bachelor’s degree in science/engineering/tech

Master’s degree preferred

Outils

eIPRRA

RA processes

Description du poste

BD is seeking a Regulatory Affairs Strategist, Globalization, to lead worldwide regulatory strategies for assigned areas. You will partner with Business Units and Regional leaders to enable compliant growth and market access through standardized processes.

The role requires a strong RA background with 8+ years in medical devices and 5+ years in regulatory affairs; RAC and a Master’s degree are a plus. On‑site collaboration is emphasized.