Job Description Summary

The Regulatory Strategy and Policy Manager position is primarily focused on tracking and providing support to the companies top new product development projects while at the same time helping to drive implementation of new innovative regulatory tools. The ideal candidate will be energetic, possess a strong regulatory background and performs well independently and as part of a team.

The Regulatory Affairs Strategy and Policy Manager will work in BD Central RA – Regulatory Strategy providing regulatory leadership to cross-functional project teams from early development to new product launches in various markets including the US, EU, and others. The incumbent will support product lifecycle management activities across BDX to ensure key programs stay on track, including direct engagement with regulatory bodies. The ideal candidate will have medical device and in vitro diagnostic experience in the US, EU, and other international regions as well as experience with RA Cybersecurity requirements and project management activities. This Manager role will also support Cybersecurity Policy as well as the International Affairs team with Global Harmonization, Regulatory Policy and Advocacy efforts within BD. The candidate should have effective communication skills for engaging with cross functional leadership and external regulatory bodies.

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. 

 About Central Regulatory Affairs:

 We thrive on innovative out of the box thinking to tackle the latest regulatory challenges across BD’s wide product portfolio.  Our team has the unique opportunity to be involved with both medical devices, in vitro diagnostics, and more; allowing you to broaden your expertise and grow in your career across a wide variety of medical products.

About the role:

In this role you will provide regulatory leadership to cross-functional project teams from early development to new product launches in various markets including the US, EU, and others. You will support product lifecycle management activities across BDX to ensure key programs stay on track with regulatory bodies. In this role you will also support Cybersecurity Policy as well as the International Affairs team with Global Harmonization, Regulatory Policy and Advocacy efforts within BD.

Key responsibilities include:

Regulatory Submissions & FDA Engagement

• Lead and support timely execution of FDA submissions including 510(k), Pre-Sub, IDE, PMA, and De Novo.
• Coordinate BDX-level FDA engagement around key risk areas.
• Assess and justify whether device changes require 510(k) submissions.

Innovative Regulatory Strategy

• Apply regulatory guidance to support innovation (e.g., PCCP, Breakthrough, STeP).
• Evaluate real-world evidence for regulatory use.
• Identify and communicate regulatory risks and mitigation strategies.

Cross-Functional Leadership & Collaboration

• Provide regulatory leadership across complex product development teams.
• Collaborate with QA and R&D to enhance design innovation and compliance.
• Support global regulatory strategy development and execution.

Training & Process Improvement

• Lead RA training initiatives across business units and regions.
• Drive continuous improvement in regulatory and design processes.

Policy, Advocacy & Standards

• Lead efforts to comply with evolving regulations (EU MDR/IVDR, MDSAP).
• Champion cybersecurity regulatory policy and standards.
• Represent BD in external organizations and standards development.

Clinical & Compliance Oversight

• Review clinical and human factors protocols for regulatory adequacy.
• Maintain SOPs and policies to ensure regulatory compliance.
• Stay current on regulatory changes and communicate impacts.

About you:

 To succeed in this role, you must demonstrate strong communication skills—both written and verbal—and excel in project management. You should be able to manage multiple competing priorities with precision and attention to detail, while applying critical thinking to solve complex challenges. The ability to work independently and deliver results on or ahead of schedule is essential. Success also requires a global perspective, a strong customer focus, and the ability to collaborate effectively across functions and teams.

Required education and experience

•  B.S. degree in a technical discipline (e.g., engineering, bioengineering, biology, chemistry)
• At least 5 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies or 3 years of experience with an advanced degree.
• At least 2 years Regulatory Policy/Advocacy experience in medical device or in vitro diagnostic device companies.
• Experience in International product registration
• Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
• Demonstrated success in the preparation and completion of regulatory submissions (PMA, 510(k), IDE) to FDA and other global regulatory agencies.
• Experience in negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical device and in vitro diagnostic areas.

Preferred qualifications:

•  RAC Medical Devices
• Advanced degree

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. 

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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 our 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 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 DC - Washington, DC

Additional Locations

Work Shift

NA (United States of America)

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

$126,600.00 - $208,900.00 USD Annual