Regulatory Affairs Lead, Promotional Materials

bdx; Franklin Lakes (NJ); Hybrid; USD 136,000 - 217,000; Full time

Benefits offered by this job

Medical coverage

Health Savings Accounts

Dental coverage

Vision coverage

Life and AD&D insurance

Paid time off

Job summary

BD in Franklin Lakes, NJ is seeking a Staff Regulatory Affairs Specialist to lead regulatory review and strategic guidance for promotional, labeling, and educational materials for Specimen Management products. You will ensure claims are truthful, substantiated, and compliant with US/EU/global requirements.

The ideal candidate has 5+ years of medical device/IVD regulatory experience, strong communication and project management skills, and the ability to influence cross‑functional teams with

Qualifications

• B.S. degree in a scientific, health sciences, engineering, regulatory, or technical discipline.
• Minimum 5 years Regulatory Affairs experience in medical device, IVD, diagnostics, life sciences, or similarly regulated healthcare products.
• Experience reviewing labeling, advertising, promotional, commercial, or customer-facing materials for regulated products.

Responsibilities

• Lead regulatory review and approval of advertising, promotional, labeling, sales, educational, trade show, launch, and customer-facing materials for Specimen Management products.
• Provide regulatory guidance to ensure claims are truthful, non-misleading, and compliant with approved labeling and evidence.
• Evaluate new or revised promotional claims and define substantiation requirements.

Skills

Regulatory affairs

Regulatory strategy

Cross-functional collaboration

Communication skills

Project management

Education

B.S. degree in a scientific/health sciences/engineering/regulatory discipline

Tools

Microsoft Word

Excel

PowerPoint

Document management systems

Job description

BD in Franklin Lakes, NJ is seeking a Staff Regulatory Affairs Specialist to lead regulatory review and strategic guidance for promotional, labeling, and educational materials for Specimen Management products. You will ensure claims are truthful, substantiated, and compliant with US/EU/global requirements.

The ideal candidate has 5+ years of medical device/IVD regulatory experience, strong communication and project management skills, and the ability to influence cross‑functional teams with