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.

Our vision for Central Regulatory Affairs at BD

Explore innovative solutions in BD Central Regulatory Affairs (RA) – Regulatory Strategy Team. Develop expertise across medical products in a collaborative environment.

This position is hybrid with required travel up to 25%. The primary office location will be Durham, NC, Franklin Lakes, NJ, or Washington, DC.

**This position does not offer relocation assistance**

About the role:

The Senior Regulatory Affairs Strategy Specialist will work in BD Central RA providing regulatory leadership to cross-functional project teams from early development to new product launches in various markets including the US, EU, and others. Activities include assessment of the regulatory impact of product changes, line extensions, and developing regulatory strategies to support new 510(k) submissions, CE marking applications, and more!

Key responsibilities will include:

• Lead collaborative sessions on policy/guidance document review and comment collection for external collaborators
• Manage participation in external working groups such as MDIC, AdvaMed, MDMA
• Coordinate the collection, processing, and maintenance of internal performance metric data
• Support Regulatory Strategy team operations, including SharePoint site maintenance and newsletter generation
• Track current regulations affecting BD products and inform relevant teams
• Act as liaison with FDA regarding product submissions and technical issues
• Review Biocompatibility, Clinical, and Human Factors protocols/reports
• Represent BD in external trade organizations and lead regulatory standards development
• Review and evaluate premarket applications to the US FDA, including 510(k), Pre-Sub, IDE, PMA, and De Novo submissions
• Support the development of internal software system capabilities
• Identify and implement improvements to current work processes
• Assess the necessity for 510(k) applications for device modifications
• Review technical files for timely CE marking of new and modified products
• Represent RA and provide actionable regulatory mentorship guidance in product development teams
• Communicate risks and mitigation approaches associated with regulatory strategies
• Support global regulatory strategies in collaboration with international regulatory associates
• Lead regulatory efforts to align with new regulations and international standards
• Develop and maintain standard operating procedures, work instructions, and policies
• Respond to requests for product information and customer questionnaires
• Carry out tasks with limited supervision

About you:

Success in this role requires a highly organized and detail-oriented individual with exceptional planning and scheduling abilities. The ideal candidate will demonstrate strong communication and project management skills, particularly in interactions with regulatory bodies, ensuring clarity and compliance throughout all phases of a project. Proficiency in Microsoft tools—including Word, Excel, PowerPoint, Power BI, SharePoint, and Project—is essential for managing documentation, data analysis, and cross-functional collaboration. The ability to juggle multiple competing priorities while maintaining accuracy and meeting deadlines is critical. A successful candidate will also possess strong critical thinking skills and the ability to work independently to achieve objectives efficiently. A global perspective, customer focus, and a collaborative mindset are key, as is a deep understanding of U.S. medical device regulations and current European quality system standards, including MDD 93/42/EEC and IVDD 98/79/EC. These competencies, combined with a proactive and adaptable approach, will enable the individual to thrive in a dynamic, compliance-driven environment.

Education and experience required:

• B.S. degree in a technical field (e.g., engineering, bioengineering, biology, chemistry); advanced degree preferred
• Minimum 5 years of Regulatory Affair