Job DescriptionIn BD - Specimen Management (BD SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Staff Regulatory Affairs Specialist position is primarily focused on compliant advertising and promotion of our existing Specimen Acquisition and Lab Specimen Management product portfolios, in addition to opportunities to provide regulatory support for new product claims. The ideal candidate will be energetic, possess a strong regulatory background and perform well independently and as part of a team.
The Staff Regulatory Affairs Specialist will work in BD - Specimen Management providing regulatory leadership to cross-functional project teams from an advertising and promotional materials standpoint. The incumbent will be responsible for regulatory review and strategic guidance for promotional, advertising, labeling, educational, sales, and commercial materials for Specimen Management products. This role ensures claims and communications are truthful, non-misleading, appropriately substantiated, aligned to approved indications/intended use, and compliant with applicable US, EU, and global medical device/IVD requirements.
The incumbent partners with Marketing, Medical Affairs, Legal, Quality, R&D, and Commercial teams to enable compliant advertising and promotional materials. The ideal candidate has strong medical device/IVD regulatory experience, sound judgment, excellent communication skills, and the ability to influence cross-functional teams with minimal supervision.
This is a hybrid position where the candidate is required to be in the office a minimum of 4 days a week. Office location is in Franklin Lakes, NJ.**This position does not offer relocation assistance**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.
Minimum Requirement:- B.S. degree in a scientific, health sciences, engineering, regulatory, or technical discipline (e.g., biology, chemistry, biomedical engineering, bioengineering, or related field).
- Minimum 5 years Regulatory Affairs experience in medical device, IVD, diagnostics, life sciences, or similarly regulated healthcare products, or an equivalent combination of education and experience.
- 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.
Knowledge and Skills- Proficient in Microsoft Word, Excel, PowerPoint, and applicable electronic review/document management systems.
- Strong written and verbal communication, technical writing, critical thinking, and project management skills.
- Demonstrated ability to influence without authority, collaborate across functions, and manage multiple priorities concurrently.
- Must have current knowledge of US, EU, and international medical device/IVD regulatory requirements related to labeling, claims, advertising, and promotion.
- Must have strong understanding of claims substantiation, intended use alignment, evidence evaluation, and fair and balanced positioning.
- Must have the ability to assess promotional risk and communicate practical, well-reasoned recommendations to Marketing, Legal, Quality, Medical Affairs, and Commercial stakeholders.
- Must be self-motivated, detail-oriented, able to work independently, maintain confidentiality, and carry out responsibilities with minimal supervision.
Salary Range Information$135,500.00 - $216,800.00 USD Annual
