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.

Why join us?

A career at BD means learning and working 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.

Become a maker of possible with us!

Our vision for Regulatory Affairs at BD

The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.

About the role

As Senior Director Regulatory Affairsyou will lead the Regulatory Affairs function for the WWIPD RA organization. This position is accountable for driving stakeholder engagement, partnering closely with MMS and MDS Leadership Teams to further the WWIPD RA strategy.

This role is responsible for the development and execution of the WWIPD RA strategy in support of the WWIPD strategic initiatives and expected to create and manage effective partnerships with regulators, including applicable Notified Bodies, US FDA, and key market regulators.

Main responsibilities will include:

• Develop the regulatory strategic roadmap and provide regulatory leadership for programs in the pre-market and post-market space for the WWIPD business.
• Provide strategic guidance to ensure alignment of regulatory strategies with business objectives and implementation of the strategic plans.
• Serves as a representative of WWIPD and Actively contribute to key strategic decisions impacting he development of regulatory policies, standards and strategies.
• Build and define regulatory pathways for new products; develops regulatory strategies and tactical plans for submissions regulatory bodies.
• Liaise with global MMS and MDS RA lead(s), to ensure strategic alignment.
• Identify and communicate potential risks and mitigations associated with regulatory strategies to stakeholders.
• Direct and contribute to the preparation and submission of U.S. [510(k)s, IDEs, and PMAs] and International regulatory filings for the business group products in accordance with policies and procedures established by the company and regulatory agencies.
• Direct the preparation of product information for product registrations.
• Incorporate Worldwide regulatory developments affecting the Business Group’s Platforms and Programs and communicate emerging opportunities and concerns to stakeholders.
• Ensure that WW ISD product labelling and promotional materials follow Corporate, and international regulations and requirements.
• Lead a staff of regulatory professionals responsible for product submission/registration activities.
• In conjunction with RA business partners, provides input into the budget process for Regulatory Affairs
• Represents the Business in interactions/negotiations with global regulatory agencies and Notified Bodies; external activities benefiting BD including trade associations, professional organizations, and standards development organizations.

About you

You are a skilled regulatory affairs leader with a proven track record in the medical device industry. You bring extensive experience in managing high-risk medical device submissions and have a deep understanding of global regulatory standards. Your strategic approach, outstanding leadership skills, and ability to collaborate across functions set you apart.

• Proficiency in high-risk medical devices, pumping systems, and electromechanical devices
• Proven success in global regulatory submissions and negotiations
• Experience in negotiating with global regulatory agencies and Notified Bodies required
• Strong project management, negotiation, and communication skills
• Current and comprehensive knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC required and EU MDR
• Current and comprehensive knowledge of US Food and Drug regulations and expertise in submission pathways
• Ability to lead and motivate multi-national teams
• Advanced certifications such as RAC, PMP, and auditing certifications are a plus

Click on apply if this sounds like you!

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.

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

Required Skills

Optional Skills

.

Primary Work Location

Additional Locations

Work Shift