Director, Regulatory Affairs

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.

Director of Regulatory Affairs is responsible for developing and implementing regulatory strategies with the Senior Director, Regulatory Management, WW IPD (“Sr Director Regulatory WWIPD”) and submissions, in support of global marketing of company products for Infusion Sets. This role reports to the Senior Director, Regulatory Management, WW IPD. The Director provides cross functional support and leadership to regulatory teams located in San Diego and Franklin Lakes in concert with final decision making in made in Switzerland on such support. There will be external contacts with US and international regulatory authorities, physician advisors, and key industry specialists. Knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization is essential.

Responsibilities:

• Drive continuous improvement initiatives and develop, under the oversight of the Sr Director Regulatory WWIPD, Regulatory strategies to enhance product quality design, regulatory compliance and customer satisfaction
• Responsible for outside of the U.S. Infusion disposable sets to ensure a system-level approach between pumps and sets, including alignment and consistency in regulatory strategy, communication with regulatory bodies and change control determination
• Act as the interface on behalf of the Sr Director Regulatory WWIPD between Worldwide IPD and MMS for Design regulatory continuity
• Lead multi-departmental and business unit teams to implement the regulatory strategies set by the Sr Director Regulatory WWIPD, with respect to the collection, documentation, analysis, and reporting of information for inclusion in Worldwide submission
• Supports members of the WW IPD Regulatory Leadership Team
• Responsible for product labeling, promotional claims, and advertisements to ensure compliance with U.S. and international laws and regulations
• Manage Regulatory Affairs platform and leads a team of Regulatory professionals in the US in alignment with the mission and vision set by the Sr Director Regulatory WWIPD
• Support change control processes and problem solving expertise to mitigate risks
• Knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization
• Manages the role’s subordinate team members (less senior managers and/or experienced professionals [in the US]). Strategic battle-tested leader, directs operational units. Inspires action, coordinates simultaneous initiatives
• Partners proactively in product development design to provide strategic guidance for development planning from the exploratory phases for new products through the ongoing compliance phases for commercialized products in concert with the commercialized recommendations provided by Sr Director Regulatory WWIPD
• Understands and anticipates detailed Regulatory expectations for approval, including precedence and changes in the regulatory landscape
• Serves as subject matter expert on corporate initiatives in support of executive leadership team initiatives on behalf of the Sr Director Regulatory WWIPD
• Prepares, coordinates, and manages regulatory audits such as 510Ks audits, and ensures timely responses to questions, non-conformities or otherwise
• Builds relationships with key advocates, regulators and internal/ external stakeholders to ensure that BD point of view is understood and carried forward
• Act as a subject matter expert (SME) at the site and functional level
• Ability to interpret medical device testing methods and statistics, as applicable

Qualifications:

• Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering, or medical-related field
• Successful track record with US and global regulatory bodies
• Minimum of nine (9) years regulatory affairs or related experience
• Minimum of four (4) years managerial experience
• Comprehensive knowledge of United States, European, and international regulations and standards covering medical devices
• Demonstrated self-starter, and highly motivated
• Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators
• Orientation for detail work product, with emphasis on accuracy and completeness
• Strong knowledge of design control documents; History Files, Device History Records, QC testing, Stability reports, etc
• Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently
• Strong project coordination, business acumen and negotiation abilities
• Proven management skills of multi-cultural, multi-national teams, leading and motivating all the Associates towards the shared goals achievement and the individual development
• Advance degree preferred
• RAC certification preferred

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. 

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. 

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, learn and improve every day.    

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   

Required Skills

Optional Skills

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Primary Work Location USA CA - San Diego TC Bldg C&D 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.

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

$179,200.00 - $322,500.00 USD Annual

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