Sr. Director, Clinical Affairs

Who We Are

ABOUT ENOVIS™

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.

• Develop and execute Enovis' global clinical evidence strategy supporting pre-market and post-market requirements across FDA, EU MDR, and international regulations.
• Define clinical plans to support new product launches, ensuring CEP, CER, PMCFP, and PMCFR are completed on time to prevent revenue delays.
• Own the clinical strategy for legacy device remediation under EU MDR to sustain market access and revenue.
• Establish global standards for clinical data collection, analysis, and reporting across all business units.

• Lead the design, execution, and oversight of clinical investigations, PMCF, PMS, and observational studies.
• Partner with internal and external medical writers to develop high-quality clinical evaluation reports, study protocols, CSRs, biocompatibility documentation, and risk management inputs.
• Perform gap analyses of clinical data to ensure ongoing certification and compliance.
• Review and approve clinical content supporting regulatory submissions and marketing materials.
• Oversee clinical monitoring activities at field sites as required.

• Ensure compliance with GCP, FDA, ISO 14155, MEDDEV 2.7.1/4, EU MDR, and global regulatory standards.
• Function as clinical lead interface with Notified Bodies for product approvals, transfers, deficiency responses, and remediation activities.
• Track, manage, and resolve clinical deficiencies, ensuring timely and strategic responses aligned with business priorities.
• Maintain readiness for audits and inspections related to clinical documentation and execution.

• Collaborate with Regulatory Affairs, Quality, R&D, Medical Affairs, Marketing, and Commercial teams to align clinical evidence with product and business strategies.
• Provide clinical regulatory support to global business units.
• Represent Clinical Affairs in project team meetings and executive forums.

• Identify and develop relationships with Key Opinion Leaders (KOLs) and Centers of Excellence globally.
• Lead advisory boards, investigator meetings, and collaborative research partnerships.
• Drive clinical evidence dissemination through publications, presentations, and educational initiatives.

• Build, lead, and mentor a cohesive global clinical affairs organization.
• Own clinical budgeting, vendor management, and resource planning to ensure delivery aligned with business objectives.
• Oversee CROs and external vendors for performance, quality, and cost efficiency.

• PhD, MD, PharmD, or master's degree in a scientific, clinical, biomedical, or related discipline.

• 10+ years of experience in Clinical Affairs or Clinical Research within medical devices, orthopedics, or other highly regulated healthcare industries.
• 5+ years of people leadership experience leading global and/or matrixed clinical organizations.
• Demonstrated success working with Notified Bodies, FDA, and international regulatory authorities to support product approvals and market access.
• Proven experience supporting Class I-III medical devices across the product lifecycle.
• Strong working knowledge of EU MDR, MDD, MEDDEV 2.7.1/4, FDA regulations, ISO 14155, and GCP.
• Experience leading product transfers, regulatory approvals, and MDR remediation programs.
• Strategic leader with the ability to translate vision into execution across complex portfolios.
• Strong program and portfolio management capability, balancing timelines, resources, and business priorities.
• Excellent scientific, clinical, and regulatory writing skills with high attention to detail and sound professional judgment.
• Ability to influence and lead effectively within a global matrix organization.
• Experience in orthopedics, prevention & rehabilitation, or surgical devices strongly preferred.
• Leadership of global PMCF and PMS programs with demonstrated impact on compliance and business outcomes.
• Track record of publications and scientific presentations in peer-reviewed forums.
• Demonstrated success building and scaling clinical organizations in growth-oriented environments.

• Driving Results: Sets ambitious, achievable goals, creates urgency, captures opportunities, and inspires teams to exceed performance expectations.
• Strategic Thinking: Develops multi-year clinical strategies aligned with enterprise objectives while anticipating regulatory, market, and portfolio changes.
• Commercial Acumen: Connects clinical evidence generation to business impact, evaluating financial implications and enabling sustainable revenue and margin growth.
• People Leadership: Builds high-performing teams by leveraging strengths, empowering decision-making, fostering collaboration, and promoting engagement.
• Ownership & Execution: Takes accountability for complex challenges, prioritizes effectively, communicates clearly, and delivers with disciplined execution.
• Values Alignment: Champions continuous improvement, collaboration, transparent accountability, thoughtful speed, and patient-focused innovation to drive exceptional outcomes and team performance.