Job Description Summary

The Manager, Regulatory Affairs, Specimen Management (SM) reports directly to the Director of Regulatory Affairs, Operations and Strategy, Specimen Management. This position is responsible for Specimen Management regulatory operational excellence at TCI and leads the SM Regulatory Affairs team at that location. The role includes responsibilities for sensing/managing the global regulatory environment, ensuring functional compliance with regulatory operations systems (RIM, registration planning), driving sustaining regulatory efforts, and enabling departmental processes, infrastructure, and efficiency improvements.

Job Description

Summary of Position: The Manager, Regulatory Affairs, Specimen Management reports directly to the Director of Regulatory Affairs, Operations and Strategy, Specimen Management. This position is responsible for the Specimen Management Regulatory Affairs operations activities at TCI.

• Represent the SM Regulatory Affairs organization as the most senior SM RA leader at TCI.
• Enables a one-team mindset at TCI and within the SM organization by partnering cross-functionally to drive key strategic initiatives.
  • Ensures SM regulatory affairs is a strategic partner to the businesses with close alignment between the regulatory strategies and tactics and the business plan.
  • Supports the development and implementation of SM-wide policies and best practices that ensure efficient and effective compliance with US FDA and international requirements.
  • Support the Regulatory Affairs function on Product Lifecycle Management (PLM)/Sustaining project teams and liaise with Regulatory Affairs subject matter experts (SMEs) to fulfill US FDA and EU CE requirements.
  • Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities to ensure regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development.
  • Develop regulatory strategies for change controls (CC) and establish Regulatory Requirements.
  • Support regulatory efforts to maintain and/or simplify technical documentation maintenance, labeling changes/remediations projects and UDI assessments.
  • Review and approve labeling and promotional material for compliance to FDA and EU regulations.
  • Support completion of EU Substantial Change Notifications and Substantial Change Applications for approval. Prepare responses to notified body inquiries.
  • Oversees the TCI SM Regulatory Affairs team and ensures strong working with relationships with other members of the SM Regulatory Affairs team and the SM organization. Accountable for the functional excellence of the TCI SM Regulatory Affairs team.
• Supports the development of departmental processes, tools, and infrastructure (e.g., RIM, PIM, DMS, etc.) and implements refined processes to enable sustaining activities within the SM RA team.
• Drives SM RA sustaining activities at TCI and interfaces with Platform RA teams to ensure provision of sustaining support.
• Supports the collection, dissemination, and implementation of regulatory intelligence that can materially affect the business.
• 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.
  • Provide training or deliver presentations to cross-functional groups across TCI and SM on salient regulatory topics.
  • Recognize potential compliance problems areas or associate ambiguity and make recommendations to resolve.

• 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.

• 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; experience with in vitro diagnostic devices a plus.
• Experience with FDA Class I and II products.
• Extensive knowledge and experience in ensuring timely submission of high-quality documents for medical device/IVD product registrations.
• Experience gaining regulatory approvals for medical devices outside of the United States.
• Skilled in 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.

• Strong business orientation - ability to communicate and interact effectively with BD business leaders at TCI and around the world.
• Demonstrated success in managing change registrations and medical device regulatory filings.
• Must inspire, motivate, and build the confidence of teams to reach goals, steadfastly pushing self and others to achieve results.
• Demonstrate success in supporting both growth and product support projects, including complex projects involving ambiguity, in a rapidly changing regulatory environment.
• Ability to leverage creative regulatory solutions to address complex problems.
• Ability to attract, recruit, mentor, and retain high-caliber professionals.