Staff Regulatory Affairs Specialist, Advertising & Promotion

About the role

BD – Specimen Management develops widely used products in specimen collection, including sample acquisition, collection containers, and emerging point-of-care applications. This Staff Regulatory Affairs Specialist position focuses on compliant advertising and promotion of existing Specimen Acquisition and Lab Specimen Management product portfolios, with 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.

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.

Qualifications

• 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.

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.
• Current knowledge of US, EU, and international medical device/IVD regulatory requirements related to labeling, claims, advertising, and promotion.
• Strong understanding of claims substantiation, intended use alignment, evidence evaluation, and fair and balanced positioning.
• Ability to assess promotional risk and communicate practical, well-reasoned recommendations to Marketing, Legal, Quality, Medical Affairs, and Commercial stakeholders.
• Self-motivated, detail-oriented, able to work independently, maintain confidentiality, and carry out responsibilities with minimal supervision.

Benefits

• Medical coverage, Health Savings Accounts, Flexible Spending Accounts, Dental coverage, Vision coverage
• Hospital Care Insurance, Critical Illness Insurance, Accidental Injury Insurance
• Life and AD&D insurance, Short-term disability coverage, Long-term disability insurance, Long-term care with life insurance
• Anxiety management program, Wellness incentives, Sleep improvement program, Diabetes management program, Virtual physical therapy, Emotional/mental health support programs, Weight management programs, Gastrointestinal health program, Substance use management program
• Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
• BD 401(k) Plan, BD Deferred Compensation and Restoration Plan, 529 College Savings Plan, Financial counseling, Baxter Credit Union (BCU), Daily Pay, College financial aid and application guidance
• Paid time off (PTO), including all required State leaves, Educational assistance/tuition reimbursement, MetLife Legal Plan, Group auto and home insurance, Pet insurance, Commuter benefits, Discounts on products and services
• Academic Achievement Scholarship, Service Recognition Awards, Employer matching donation, Workplace accommodations
• Adoption assistance, Backup day care and eldercare, Support for neurodivergent adults, children, and caregivers, Caregiving assistance for elderly and special needs individuals, Employee Assistance Program (EAP)
• Paid Parental Leave, Support for fertility, birthing, postpartum, and age-related hormonal changes
• Bereavement leaves, Military leave, Personal leave, Family and Medical Leave (FML), Jury and Witness Duty Leave

Schedule

Hybrid position requiring in-office presence a minimum of 4 days per week at the Franklin Lakes, NJ location. This position does not offer relocation assistance.

Pay

$135,500.00 - $216,800.00 USD annual