Vice President, Regulatory Affairs, SS

Integra LifeSciences•Columbia, MD

8d•$225,400 - $316,250

About The Position

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.

Requirements

Bachelor’s degree in Science, Engineering, Regulatory Affairs, or other technically related field required
Minimum of 15 years related experience with increasing responsibility in an FDA regulated industry such as Medical Devices, Biotech, or Pharma; or at least 10-12 years of specific regulatory experience with a master’s degree; or 8-10 years of specific regulatory experience with a Doctorate/PhD degree.
At least 5 years of experience managing people, leading teams, or providing functional leadership is preferred.
Demonstrated success developing and executing regulatory strategies within the MedTech industry, preferably for specialty surgery, implantable devices, neurosurgical, reconstruction, biologics, combination products, or related product portfolios, including experience with complex submissions such as Class III PMA, IDE, pre-submissions, 510(k)s, technical files, design dossiers, or international registrations.
Strong ability to work with diverse stakeholders, build collaborative relationships, and manage competing priorities across functional departments.
Proven ability to operate successfully in a global matrix environment and coordinate cross-functional efforts across the Specialty Surgery Division to resolve regulatory issues and advance business priorities.
Demonstrates sound judgment in balancing regulatory compliance, patient safety, product quality, and business needs.
Strong executive leadership, project leadership, people leadership, collaboration, and communication skills, including the ability to present complex division regulatory issues clearly, influence senior-level decision-making, and make timely, high-quality recommendations in ambiguous situations.
Strategic Regulatory Leadership: Anticipates regulatory risks and opportunities, translates division priorities into practical regulatory strategies, and guides teams through complex decision-making.
Division and Enterprise Partnership: Builds trusted partnerships across Specialty Surgery, Regulatory Affairs, Quality, Operations, Product Development, Commercial, Legal, Medical Affairs, and international teams.
Influence Without Authority: Aligns cross-functional stakeholders, resolves competing priorities, and drives timely decisions in a matrixed environment.
Regulatory Judgment and Risk-Based Decision-Making: Balances regulatory compliance, patient safety, product quality, business objectives, and speed to market using sound, defensible judgment.
Talent Development and Coaching: Develops regulatory talent, strengthens team capability, provides clear feedback, and supports succession readiness.
Accountability and Execution Discipline: Owns commitments, follows through on regulatory priorities, and ensures high-quality deliverables are completed on time.
Change Leadership: Leads teams through evolving regulatory requirements, business transformation, portfolio changes, and process improvement.
Executive Communication: Communicates complex regulatory issues clearly and concisely to senior leaders, cross-functional partners, and external regulatory stakeholders.
Collaboration and Inclusion: Creates an environment where diverse perspectives are heard, decisions are transparent, and teams work effectively across silos.
Continuous Improvement Mindset: Identifies opportunities to simplify processes, improve quality, and increase efficiency across division regulatory activities.

Nice To Haves

Master’s degree in Science, Engineering, Business, Regulatory Affairs, or related discipline preferred.
Certification in Regulatory Affairs Professional Society (RAC) encouraged.
RA Certification (RAC) can count towards 1 year of specific RA experience
Master's degree can count towards 2 years of relevant (non-RA) experience
Terminal degree (Doctorate or PhD in Business, Science, or related discipline) can count towards 4 years of relevant (non-RA) experience.

Responsibilities

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.