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.