Job ID R-523348 Date posted 08/03/2025

Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.

  • Job Type:
    Full-Time
  • Job Level:
    Entry to Senior
  • Travel:
    Varies
  • Salary:
    Competitive
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Responsibilities

Job Description Summary

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. 

The Regulatory Affairs (RA) Director is responsible for the management and setting the direction for the Medication Delivery and Vascular Care (MDVC) business platform within the Medication Delivery Solution Business Unit.  The RA Director is responsible for developing and implementing regulatory strategies and submissions in support of global marketing within the MDVC platform.  The RA Director will work with external contacts, with US and international regulatory authorities, physician advisors, and key industry specialists as related to their product platform. The RA Director must be knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization.

Responsibilities:

  • Manages and directs work for multiple product families, RA projects, or a Regulatory Affairs Platform.

  • Provides regulatory leadership for respective platform, product families, or RA program(s), and manages RA managers and individuals working withinareas of responsibility.

  • Recruits, develops, and manages RA professionals with varying levels of seniority, experience, and skills, and ensures regulatory milestones assigned to individuals within area of responsibilityare met.

  • Responsible for the management of RA Professionals within the respective platform(s) or program(s), and structures projects appropriately to ensure work is completed efficiently and effectively.  

  • Develops managers and technical leaders by making accurate assessments of individuals’ capabilities and performance, and provides feedback, coaching, guidance, and mentoring.

  • Manages and directs budget related to Platform and/or projects, including submission costs, travel, and training for teammates.

  • Partners proactively in the product development process to provide strategic guidance for development planning from the exploratory phases for new products through the ongoing compliance phases for commercialized products.

  • Represents Regulatoryin BusinessUnit meetings and product reviews.

  • Understands and anticipates detailed Regulatory expectations for approval, including precedence and changes in the regulatory landscape.

  • Manages communications and negotiates with regulatory agencies on behalf of the business, as they pertain to regulatory decisions and strategies. 

  • Critically assesses impact of studies and data on project outcome

  • Influences all parties to ensure successful submission outcomes, including submission content management.

  • Coordinates with Quality function on recall strategies and responses to quality audit findings.

  • Ensures consistency of messages delivered via advertising and promotion material in all arenas exposed to customer, as well as for sales training. 

  • Developsand approves regulatory policies, goals, and executive reports.

  • Communicates internal Regulatory Affairs procedures and policies, as needed.

  • Represents RA in due diligence and participates in product acquisition teams.

  • Develops and influences government position and political decisions in partnership with Legal and Government Affairs.

  • Builds relationships with key advocates, regulators and internal/ external stakeholders to ensure that BD point of view is understood and carried forward.

Qualifications:

  • Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a minimum of nine years of experience, or equivalent combination of related education and experience

  • Preferred minimum of ten-to-fifteen years of experience in the medical device industry, with at least nine years in a regulatory role.

  • Comprehensive knowledge of United States, European, and international regulations and standards covering medical devices.

  • Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results.

  • Experienced in continuous improvement projects, project management, product development processes, and design control.

  • Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently.

  • Effectively copes with change and can comfortably handle risk and uncertainty

  • Prior management experience.

  • Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. 

  • Ability to be effective in complex projects with ambiguity and/or rapid change.

  • Demonstrated self-starter, and highly motivated.

  • Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators.

  • Ability to interpret medical device testing methods and statistics, as applicable.

  • Knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization. 

  • Advance degree preferred. 

  • RAC certification.

  • Experience with Clinical Trial applications (US IDE).

  • Medical device experience in Medication Delivery and Combination Products.

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. 

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. 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.

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. You will work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

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.

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 UT - Salt Lake City BAS

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$187,400.00 - $337,300.00 USD Annual
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Success Profile

What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.

  • Analytical
  • Collaborative
  • Communicator
  • Persuasive
  • Problem-solver
  • Skilled presenter

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