Sr. Director, Strategic Regulatory Affairs and UDI

Sr. Director, Strategic Regulatory Affairs and UDI

The Senior Director, Strategic Regulatory Affairs & UDI provides leadership and oversight for global regulatory operations, regulatory systems, unique device identification (UDI), regulatory data governance, import/export regulatory compliance support, and regional Regulatory Affairs and Quality functions. This role is accountable for establishing organizational strategy, operational excellence, governance frameworks, and organizational capability across multiple regulatory and compliance disciplines. The position leads a global organization through a team of managers and functional leaders and serves as a key partner to Regulatory Affairs, Quality, Supply Chain, Manufacturing, Information Technology, Commercial, and Executive Leadership teams to ensure regulatory compliance, support global market access, and enable business growth.

Principal Responsibilities

• Organizational Leadership
• Strategic Regulatory Operations & Governance
• UDI, Regulatory Data & Systems Leadership
• Regional & Global Compliance Oversight
• Cross-Functional & Executive Leadership

Education / Experience Requirements

Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related discipline required; Advanced degree preferred. Minimum 12 years of progressive leadership experience within Regulatory Affairs, Regulatory Operations, Quality, Compliance, Medical Device Operations, Healthcare Operations, or related regulated industries. Demonstrated success leading managers and complex, multi-functional organizations. Experience establishing governance frameworks, operating models, and organizational strategies. Experience leading large-scale process improvement, systems implementation, or business transformation initiatives. Experience operating within highly regulated global environments. Experience leading geographically dispersed teams and organizations preferred. Exceptional leadership skills and proven experience in leading, advising, inspiring, educating, and developing high-performance teams. Excellent interpersonal and communication skills with the ability to communicate effectively across all areas of the business. Strategic thinking and business acumen. Executive presence and influence. Change management and transformation leadership. Cross-functional collaboration and stakeholder management. Strong analytical and problem-solving capabilities. Advanced skills in the Microsoft office suite.

Specialized Skills / Other Requirements

People Managers: All managers are responsible for the following: Organization Capability, Cross-functional Alignment, Continuous Improvement, Culture and Values.

The pay range for this position at commencement of employment is expected to be between $203,000 - $253,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Travel Required: Up to 25%

Working Environment: Office/Professional Plant/Manufacturing Remote/Field Laboratory