Vice President, Regulatory Affairs, SS

SUMMARY

The Vice President, Regulatory Affairs, Specialty Surgery Division is an executive regulatory leader responsible for providing strategic regulatory and compliance leadership for the Specialty Surgery Division, including divisional product portfolios, development programs, lifecycle activities, and cross-functional business priorities. This role partners with Global Regulatory Affairs leadership, Specialty Surgery business leaders, Quality, Operations, Product Development, Commercial, Legal, Medical Affairs, and other stakeholders to develop and execute regulatory strategies that support product development, submissions, lifecycle management, advertising and promotion review, and global registrations for the division.

The Vice President provides leadership to regulatory teams supporting Specialty Surgery and contributes to the interpretation, implementation, and governance of applicable US, EU, Canadian, and global regulatory requirements. This role also supports engagement with FDA, notified bodies, and international regulatory authorities, while identifying emerging regulatory issues, compliance risks, and opportunities that may impact the division’s portfolio and business objectives.

Develop, recommend, and execute regulatory strategies for Specialty Surgery products, projects, and business priorities to support compliance with current and emerging regulations in the US, EU, Canada, and global markets. Provide expert regulatory input for Specialty Surgery business development activities, including potential mergers, divestitures, acquisitions, licensing opportunities, and portfolio assessments, as requested. Lead regulatory strategy development for Specialty Surgery new product development, sustaining projects, design changes, manufacturing changes, and lifecycle management activities to ensure global regulatory requirements are met.

Monitor and interpret emerging regulations, guidance documents, and industry trends relevant to the division’s product portfolio; identify potential compliance gaps and recommend mitigation plans. Partner with Specialty Surgery business and functional leaders to support regulatory strategies for new product development, continuous improvement, manufacturing changes, commercial objectives, and portfolio priorities. Provide executive oversight and guidance for division regulatory activities from concept through submission, clearance, approval, registration, launch, and post-market lifecycle management.

Ensure division regulatory processes and deliverables are aligned with business objectives, quality system requirements, and applicable regulatory expectations. Serve as a senior regulatory representative and liaison with FDA, notified bodies, and other local, national, and international regulatory authorities for the division’s products, as appropriate. Collaborate with Quality and cross-functional partners to support compliance activities related to the division’s products, including FDA, ISO, EU MDR, and other applicable quality system and regulatory requirements.

Oversee preparation, review, and submission activities for applicable division regulatory pathways, which may include 510(k) Premarket Notifications, IDEs, PMAs, Design Dossiers, Technical Files, and international registrations. Support strategic planning, resource forecasting, budget inputs, and organizational capability planning for division regulatory programs and team responsibilities. Provide leadership, coaching, and mentoring to regulatory team members supporting Specialty Surgery; support career development and promote regulatory best practices aligned with Integra values.

Lead and contribute to continuous improvement, regulatory transformation, and process harmonization initiatives within division Regulatory Affairs and across cross-functional division processes. Perform other relevant duties as assigned.

EDUCATION & EXPERIENCE

Bachelor’s degree in Science, Engineering, Regulatory Affairs, or other technically related field required;
Master’s degree in Science, Engineering, Business, Regulatory Affairs, or related…