Associate Director, Regulatory Affairs, Specimen Management

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.

BD’s Specimen Management Regulatory Affairs organization is the keystone of Specimen Management’s product registration efforts, connecting internal and external stakeholders to deliver safe, effective, and innovative diagnostic collection and care devices to patients and customers in alignment with business priorities and global regulations.

About the Role:

In this role you will lead regulatory strategies and ensure compliance, driving growth and innovation in our team.

Key responsibilities will include:

• Leading BD’s Specimen Management Regulatory Affairs team for the Specimen Acquisition Platform.
• Collaborating with SM business leaders and functions to drive initiatives and execution.
• Aligning regulatory strategies with business plans to foster growth, innovation, and profitability.
• Developing and implementing policies to ensure compliance with FDA, EU MDR, and international requirements.
• Acting as the primary contact for regulatory agencies, providing documentation, and ensuring comprehensive review.
• Leading regulatory audits and preparing regulatory records and documentation.
• Advocating favorable regulations for timely patient access to products.
• Driving SM RA strategies for New Product Development and sustaining efforts.
• Building strong regulatory capabilities and leadership within the team.

About you:

You are a problem solver who excels in simplifying complex issues within broader business contexts, with a proven track record in regulatory submissions and negotiations. Your leadership encourages high-performing teams, embraces diverse perspectives, and uses innovative solutions to drive growth and compliance.

Education and experience required:

• At least 10 years of experience in the IVD/medical device field with growing responsibility.
• Minimum 3 years of management experience.
• Proven success in developing systems for regulatory submissions and acquiring timely approvals.
• Extensive knowledge of global regulatory strategies and experience with FDA Class I and II products.
• Significant experience with EU MDR or equivalent experience and Notified Body engagements.
• Demonstrated ability in regulatory advocacy, policy, and recruiting high-performance RA teams.
• Success in large, matrix-managed organizations, partnering with MA, QA, and R&D.
• Comprehensive knowledge of regulatory requirements in the U.S., EU, and other international markets.

Click on Apply if this sounds like you!

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 learn and 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. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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 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.

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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.

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