Regulatory Affairs Manager – RA Strategy Lead; hybrid

Job Description Summary

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 Med Tech 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.

Working closely with the Director of Regulatory Affairs, the Regulatory Affairs Manager — RA Strategy Lead will provide proactive regulatory surveillance. They will develop regulatory strategies for product creation and market entry. They will also serve as the regulatory advisor on innovation teams. This role is critical for proactively identifying regulatory changes and effectively communicating them to the business, ensuring swift understanding and compliance planning.

This position will support the innovation council by providing upfront regulatory assessments to help guide planning through timely concept and product development. The role will engage in policy shaping to allow the business to navigate the regulatory landscape effectively.

• Proactively monitor global regulatory developments to identify potential impacts on product portfolio and deliver timely and actionable insights to stakeholders, ensuring alignment with business strategy.
• Collaborate with cross-functional teams to develop plans addressing evolving regulations and standards that support product innovation and entry into markets.
• Serve as a regulatory advisor to innovation teams, providing mentorship on compliance and guidelines throughout the product lifecycle. Facilitate knowledge sharing to integrate regulatory considerations early in the development process.
• Assess potential regulatory risks associated with product development and market strategies. Propose and implement mitigation strategies to safeguard our innovation efforts.
• Responsible for effectively communicating trends in regulatory changes early to the organization. Ensure that all teams are informed and prepared to adapt to upcoming changes, fostering a proactive compliance culture.
• Champion a culture of regulatory excellence by providing training and support to internal teams. Foster awareness and understanding of regulatory obligations across the organization.

Bachelor’s degree required in Life Sciences, Engineering, or a related field.

Minimum of 5 years of experience in regulatory affairs within the medical device industry.

• Comprehensive understanding of medical device regulations, standards, and the regulatory submission landscape (e.g. FDA, EU MDR, EU IVDR, ISO).
• Proven experience in developing and implementing regulatory strategies.
• Exceptional analytical and strategic thinking abilities.
• Strong communication and interpersonal skills, with a proven ability to influence stakeholders.
• Effective project management skills and attention to detail.
• Proactive, adaptable, and results‑driven, with a passion for regulatory excellence and innovation.
• Ability to work collaboratively in a cross functional team environment.
• Knowledge of quality management systems and risk management principles.

$ –  USD Annually

Primary

Work Location:

USA NJ – Franklin Lakes. 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”.

Annual Bonus Potential Discretionary LTI Bonus Health and Well‑being Benefits Medical coverage Health…