Regulatory Affairs Specialist – Med Devices/IVD (Hybrid)

Regulatory Jobs; Franklin (NJ); Hybrid; USD 136,000 - 217,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

BD in USA (NJ) seeks a Staff Regulatory Affairs Specialist to lead regulatory review of promotional materials for Specimen Management products. You will guide cross-functional teams to ensure truthful, substantiated claims and compliant labeling across US/EU/global requirements.

The role requires strong regulatory experience in medical devices/IVDs, excellent communication, and the ability to influence without authority. Hybrid work with in-office presence is required.

Qualifications

• BS degree in a scientific, health sciences, engineering, regulatory or technical discipline.
• Minimum 5 years Regulatory Affairs experience in medical device/IVD or similar regulated healthcare products.
• Experience reviewing labeling, advertising, promotional, or customer-facing materials.
• Experience supporting cross-functional product teams and launches.
• Experience with claims substantiation and promotional governance preferred.

Responsibilities

• Lead regulatory review and approval of advertising, promotional, labeling, sales, educational, and promotional materials for Specimen Management products.
• Provide regulatory guidance to ensure claims are truthful, substantiated, and compliant with labeling and evidence.
• Evaluate promotional claims and define evidence needed for substantiation.
• Oversee new and differentiated product claims, including data interpretation and documentation.
• Partner with Marketing, Medical Affairs, Legal, Quality, R&D, and Commercial teams to support compliant materials.
• Represent RA on review committees and communicate regulatory risks and mitigation options.
• Monitor regulations and trends to inform promotional strategy and internal review practices.
• Support global launch readiness and lifecycle management activities through labeling changes and line extensions.
• Develop procedures, templates, and training related to promotional review and governance.
• Perform other duties as assigned.

Skills

Regulatory affairs

Cross-functional collaboration

Communication skills

Project management

Medical device/IVD regulations

Education

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

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

BD in USA (NJ) seeks a Staff Regulatory Affairs Specialist to lead regulatory review of promotional materials for Specimen Management products. You will guide cross-functional teams to ensure truthful, substantiated claims and compliant labeling across US/EU/global requirements.

The role requires strong regulatory experience in medical devices/IVDs, excellent communication, and the ability to influence without authority. Hybrid work with in-office presence is required.