Director, Regulatory Affairs, Specimen Management

Job Description Summary

The Director, Regulatory Affairs, Specimen Management reports directly to the VP Regulatory Affairs, Specimen Management. This position is responsible for the Specimen Management Regulatory Affairs operations and strategy activities, including international registrations, sustaining support, and regulatory advocacy.

The Director, Regulatory Affairs, Specimen Management (SM) reports directly to the Vice President, Regulatory Affairs, Specimen Management. This position is responsible for Specimen Management regulatory operational excellence and strategy that supports the SM business growth agenda. The role includes responsibilities for sensing/managing the global regulatory environment, establishing and executing a regulatory advocacy/influencing roadmap, ensure function compliance with regulatory operations systems (RIM, registration planning), leading sustaining regulatory efforts, driving the international regulatory strategy for SM, and overseeing departmental processes and infrastructure. This role will sit at the SM RA Leadership Team.

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.

Summary of Position: The Director, Regulatory Affairs, Specimen Management reports directly to the VP Regulatory Affairs, Specimen Management. This position is responsible for the Specimen Management Regulatory Affairs operations and strategy activities, including international registrations, sustaining support, and regulatory advocacy.

Job Description

The Director, Regulatory Affairs, Specimen Management (SM) reports directly to the Vice President, Regulatory Affairs, Specimen Management. This position is responsible for Specimen Management regulatory operational excellence and strategy that supports the SM business growth agenda. The role includes responsibilities for sensing/managing the global regulatory environment, establishing and executing a regulatory advocacy/influencing roadmap, ensure function compliance with regulatory operations systems (RIM, registration planning), leading sustaining regulatory efforts, driving the international regulatory strategy for SM, and overseeing departmental processes and infrastructure. This role will sit at the SM RA Leadership Team.

RESPONSIBILITIES:

• Proactively supports the SM business growth with the one-team mindset by partnering with SM business leaders and other functions on key strategic initiatives and driving prioritization and execution.
• Ensures SM regulatory affairs is a strategic partner to the businesses with close alignment between the regulatory strategies and tactics and the business plan – to drive growth, innovation, and profitability.
• Develops and implements SM-wide policies and best practices that ensure efficient and effective compliance with FDA and international requirements.
• Engages with FDA and other regulatory bodies, industry trade associations, SM Leadership teams, and Corporate Regulatory Affairs.
• Oversees departmental processes, tools, and infrastructure (e.g., RIM, PIM, DMS, etc.).
• Manages sustaining teams and interfaces with Platform RA teams to ensure provision of sustaining support.
• Provides regulatory leadership for SM’s cost-to-win initiatives.
• Coordinates the collection, dissemination, and implementation of regulatory intelligence that can materially affect the business.
• Drives SM’s regulatory advocacy/policy strategy and innovation pipeline, creating and executing a regulatory influencing roadmap in alignment with business objectives.
• Advocates favorable regulations and guidelines that support timely patient access to safe/effective products.
• Contributes to the SM Warning Letter remediation by strongly guiding and coaching the organization, aligning with overall SM strategy.
• Accountable for the functional excellence of the SM international regulatory affairs team.
• Ensures continuous global license renewal and support for SM’s international registrations, interfacing with country representatives to support global registration strategies as necessary.
• Drives overall international regulatory strategy in alignment with business and country prioritization and resourcing.
• Partners with cross-functional colleagues to identify opportunities for regulatory innovation.
• Drive the creation of SM RA strategies, such as those related to UDI and competitive intelligence.
• Establishes and regulatory reports metrics for the SM RA organization.
• Identify, develop, and coach key regulatory talent.
• Build strong capabilities and leadership skills and the culture of growth mindset, accountability, and innovation within RA team.
• Develops regulatory talent management programs to create a sustainable pipeline of talent.
• As a SM Leadership Team member, contributes to building a high functioning leadership team; embodies and drives the desired culture and behaviors across the organization.
  

EDUCATION:

• Required - Bachelor of Science degree in a technical discipline (e.g., biology, chemistry or engineering).
• Advanced degree (MS, PhD, etc.) preferred.
• RAPS Regulatory Affairs Certification (RAC) preferred.
  
  

EXPERIENCE:

• 10+ years of industry experience with 5+ years leading a Regulatory Affairs team.
• Demonstrated track record of success in leading all areas of regulatory affairs for medical devices, specifically in vitro diagnostic devices.
• Experience with FDA Class I and II products.
• Extensive knowledge and experience in designing global regulatory strategies and ensuring timely submission of high-quality documents for medical device/IVD product registrations.
• Significant experience gaining regulatory approvals for medical devices outside of the United States.
• Demonstrated experience in regulatory advocacy and policy.
• A proven track record of recruiting, developing, upskilling and retaining a high-performance RA team.
• Past success operating in a large, matrix-managed organizations with strong partnership across cross-functional teams especially with MA, QA, and R&D.
• Experience with probability-based scenario playing to drive recommendations.
  
  

SPECIAL SKILLS:

• Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
• Strong business orientation - ability to communicate and interact effectively with senior BD business leaders in US and around the world.
• Demonstrated success in filing and completing (including negotiations) many regulatory submissions/dossiers (e.g., 510(k), IDE, EU Technical Files).
• Must inspire, motivate, and build the confidence of teams to reach goals, steadfastly pushing self and others to achieve results.
• Demonstrate leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed.
• Demonstrate success in supporting both growth and product support projects, including complex projects involving ambiguity, in a rapidly changing regulatory environment.
• Experienced in meeting with, making presentations to, negotiating with, and influencing regulators.
• Demonstrated success in developing strong working relationships with regulators and external groups (e.g., trade associations) to influence effectively and bring about consensus on policies that support business objectives.
• Ability to leverage creative regulatory solutions to address complex problems.
• Ability to attract, recruit, mentor, and retain high-caliber professionals.
  
  

KNOWLEDGE OF SPECIFIC PROCEDURES / PRACTICES:

Comprehensive knowledge of regulatory requirements and strategies applying to medical devices and in vitro diagnostic devices in the U.S., EU, Canada, Japan, Asia Pacific, and Latin America. Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.

TRAVEL REQUIREMENTS:

Ability to travel US and OUS approximately 15-30%

NUMBER OF INDIVIDUALS SUPERVISED:

Oversees a function of 5 or more professional associates.

BUDGET:

Contributes to the planning and management of the budget for the SM RA function.

POLICY IMPLEMENTATION:

Applicable BD and SM policies relating to Human Resources, Regulatory and Quality, and Ethics.

COMPLEXITY:

Highly complex. This position influences the development of SM business group strategic plans and provides important input into key business decisions. Regulatory assessments and recommendations influence the product portfolio plans, scientific or technical direction of product design and/or development. Erroneous decisions or recommendations may cause delays in meeting business objectives, including financial goals. The incumbent is expected to demonstrate highly advanced skills and knowledge as a business leader in regulatory matters.

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, 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.

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

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.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift