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We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
In 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.
Our people make all the difference in our success. Join us in our mission to advance the world of health.
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.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Health and Well-being Benefits
Other Well-being Resources
Retirement and Financial Well-being
Life Balance Programs
Other Life Balance Programs
Leave Programs
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
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Primary Work Location
USA NJ - Franklin Lakes
Additional Locations
Work Shift
NA (United States of America)
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
$135,500.00 - $216,800.00 USD Annual
4 office days / week – Based on location and role requirements.
A little flex time – Based on role requirements.
Company employees:
Office Locations
