Promotional Regulatory Lead - MedTech Devices

BD; Wyckoff (NJ); Hybrid; USD 120,000 - 150,000; Full time

Job summary

BD is a leading global medical technology company committed to advancing the world of health. The Staff Regulatory Affairs Specialist role focuses on advertising and promotional materials compliance for Specimen Management products, working with cross-functional teams to ensure truthful, substantiated claims that align with regulatory requirements in the US, EU, and globally.

The position requires a strong regulatory background, effective communication, and the ability to influence 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.
• Experience supporting cross-functional product teams, marketing/commercial teams, launch activities, change assessments, and risk-based regulatory decisions.
• Experience with medical device or IVD claims substantiation, performance evidence, labeling requirements, promotional review processes, and competitive claim governance preferred.

Responsibilities

• Lead regulatory review and approval of advertising, promotional, labeling, sales, educational, trade show, launch, and customer-facing materials for Specimen Management products.
• Provide clear, risk-based regulatory guidance to ensure product claims, messaging, graphics, and comparisons are consistent with approved labeling, intended use, registrations, technical documentation, and supporting evidence.
• Evaluate new or revised promotional claims, including performance, clinical, workflow, usability, economic, environmental, and comparative claims, and define evidence needed for appropriate substantiation.
• Provide regulatory oversight for new and differentiated product claims, including review of protocols, test methods, comparator selection, data interpretation, statistical support, claim wording, limitations, and documentation.
• Partner with Marketing, Medical Affairs, Legal, Quality, Clinical, R&D, and Commercial teams to support compliant advertising and promotional materials.
• Represent RA on promotional review committees/material review boards and communicate regulatory risks, options, and mitigation approaches to stakeholders.
• Monitor relevant regulations, guidance, standards, enforcement trends, and new and differentiated claims activity to inform promotional strategy and internal review practices.
• Support regulatory core team members in global launch readiness and lifecycle management activities by assessing promotional impact of labeling changes, NPDs, and line extensions.
• Develop or improve procedures, work instructions, templates, and training related to promotional review, claims substantiation, and new and differentiated claim governance.
• Perform other duties as assigned.

Skills

Regulatory Affairs

Medical Device

Cross-functional

Regulatory labeling

Claims substantiation

Project management

Education

BS in science/engineering

Tools

MS Office

Job description

BD is a leading global medical technology company committed to advancing the world of health. The Staff Regulatory Affairs Specialist role focuses on advertising and promotional materials compliance for Specimen Management products, working with cross-functional teams to ensure truthful, substantiated claims that align with regulatory requirements in the US, EU, and globally.

The position requires a strong regulatory background, effective communication, and the ability to influence teams with