Sr. Director, Clinical Affairs, Schwyz

Job Title Senior Director, Clinical Affairs, Intl. P&R

The Role Senior Director, Clinical Affairs is a strategic leadership role responsible for developing and executing Enovis’ global clinical evidence strategy across Prevention&Rehabilitation and medical device portfolios. The position leads the planning, execution, and oversight of Clinical Investigations, Post‑Market Clinical Follow‑Up (PMCF), Clinical Evaluation (CEP/CER) and regulatory‑facing clinical documentation to support product approvals, market access and sustained revenue growth.

Operating within a matrix organization, this leader partners cross‑functionally with Regulatory, R&D, Medical Affairs, Quality, Marketing and regional business units to ensure clinical compliance with FDA, EU MDR, MDD and global regulatory requirements for Class I‑III devices. The role also builds and manages a high‑performing global clinical team while engaging Notified Bodies, KOLs and external partners to generate robust clinical evidence.

Key Responsibilities

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, PMCF 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 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.

Act 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.

Education

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

Ideal Experience&Qualifications

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.

Leadership Capabilities&Behaviors

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, prioritises 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.

Equal Employment Opportunity Enovis provides equal employment opportunities based on merit, experience and other work‑related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict withEnovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

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