Sr Regulatory Affairs Strategy Specialist

Senior Regulatory Affairs Strategy Specialist

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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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.

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 toolsincluding Word, Excel, PowerPoint, Power BI, SharePoint, and Projectis 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 Affairs experience in medical device or in vitro diagnostic device companies or 3 years of experience with an advanced degree
• Demonstrated ability to resolve problems and make appropriate regulatory decisions under pressure
• Demonstrated success in the preparation and completion of regulatory submissions to FDA and other global regulatory agencies
• Experience in negotiating with regulatory authority personnel in medical device and in vitro diagnostic areas
• International product registration experience preferred

Click on Apply if this sounds like you!

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.

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.

At BD, we are strongly committed to investing in our associatestheir 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

Required Skills

Optional Skills

Primary Work Location: USA NC - Durham - Davis Drive

Additional Locations

Work Shift