Job Description Summary

The Senior Regulatory Affairs Manager will provide strategic leadership to support new product development (NPD) programs for our global business unit portfolio. This role involves providing regulatory guidance and support throughout all stages of NPD, including supporting submissions for market access in multiple geographies. The position also involves providing guidance on post-market activities such as labeling changes, CAPAs, MDR/IVDR compliance, and supporting customer complaints. Candidates will be expected to work onsite Monday through Thursday at one of the BD locations listed on the job posting.

Job Description

We are the makers of possible

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.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Primary Responsibilities

• Lead cross functional teams by acting as the primary point of contact between the business units and regulatory affairs team.  

• Develop robust strategy plans and timelines to achieve project milestones for assigned projects.

• Provide oversight of regulatory approvals, registrations, listings, and notifications, working closely with internal team members and external consultants.

• Support preparation of regulatory documentation and actively engage with health authorities during the review process.

• Actively manage projects through all phases of clinical trial research and commercialization, ensuring timely completion of tasks and adherence to established processes.

• Participate in design control reviews and support implementation of corrective actions as needed.

• Collaborate with Quality Control and other functions to assess product quality issues and support remediation efforts.

• Review promotional materials and ensure they are consistent with approved claims and are compliant with local regulations.

• Stay abreast of evolving regulatory requirements and developments in medical device industry.

About You:

• Minimum bachelor’s degree or equivalent required; Master’s degree preferred.

• Minimum 5 years of relevant experience in medical devices or pharmaceuticals, preferably within Regulatory Affairs or a related field.

• Proven ability to lead and influence across multiple fields, including engineering, manufacturing, sales, marketing, finance, legal, and supply chain.

• Strong interpersonal skills and ability to communicate effectively at all levels of the organization.

• Experience working in a matrix environment, establishing relationships and influencing decisions across organizational boundaries.

• Proficiency in Microsoft Office Suite applications (Word, Excel, PowerPoint).

• Knowledge of European Medical Device Directives (MDD), EU MDR/IVDR, FDA QSR, ISO standards, ICH guidelines, and other applicable regulatory requirements.

• Excellent problem solving, prioritizing, and time management skills.

• Ability to work independently and make sound judgements.

• Proactive self-starter who can operate successfully in a dynamic environment.

• Fluent English language skills required; additional languages beneficial.

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.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status. 

Required Skills

Optional Skills

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

USA NC - Research Triangle Park, USA RI - Warwick

Work Shift

NA (United States of America)