Global Regulatory Strategist - Labeling & eIFU Excellence

BD; Franklin Lakes (NJ); On-site; USD 138,000 - 220,000; Full time

Benefits offered by this job

Annual Bonus

Discretionary LTI Bonus

Medical coverage

Dental coverage

Vision coverage

Life and AD&D insurance

401(k) Plan

DailyPay

Job summary

BD in Franklin Lakes, NJ, seeks a Regulatory Affairs Strategist, Globalization, to align and execute worldwide regulatory strategies for labeling, eIFU, registrations and device listings. You will partner with business units and regional leaders to standardize processes and share best practices across the organization.

The role requires 8+ years in medical devices, with 5+ in Regulatory Affairs, a science or engineering degree, and RAC if possible.

Qualifications

• Bachelor’s degree in science, engineering, or technology.
• Minimum 8 years of experience in the medical device industry, with at least 5 years in Regulatory Affairs.

Responsibilities

• 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 for consistency and scalability.
• Act as strategic partner to Business Units and Regional Regulatory leaders to enable implementation of labeling and eIFU programs.
• Coordinate and network across Business Units, Regions, Central RA, and other functions.

Skills

Regulatory affairs

Labeling

eIFU

Establishment regs

Device listings

Regulatory strategy

Cross-functional

Risk assessment

Decision quality

Communication

Education

Bachelor's in STEM

Master's degree (preferred)

RAC (preferred)

Job description

BD in Franklin Lakes, NJ, seeks a Regulatory Affairs Strategist, Globalization, to align and execute worldwide regulatory strategies for labeling, eIFU, registrations and device listings. You will partner with business units and regional leaders to standardize processes and share best practices across the organization.

The role requires 8+ years in medical devices, with 5+ in Regulatory Affairs, a science or engineering degree, and RAC if possible.