Senior Clinical Affairs Director

What You'll Do

At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence, with the goal of transforming medical technology as we know it.

Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself.

As a key member of International P&R, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

The 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. This role 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, IIa, IIb, and 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.

Reporting to the Chief Regulatory, Quality & Clinical Officer, the Senior Director, Clinical Affairs is accountable for defining and executing Enovis’ global clinical evidence strategy to support regulatory approvals, market access, and sustainable revenue growth across the portfolio. This leader owns the end-to-end clinical lifecycle, including Clinical Investigations, Clinical Evaluation, PMCF/PMS, and global regulatory-facing clinical documentation, while partnering closely with Regulatory, R&D, Quality, and Commercial teams to ensure alignment with business priorities.

The Senior Director will foster a culture of scientific excellence, collaboration, and operational discipline, building and leading a high-performing global clinical organization. They will attract, develop, and retain top clinical talent, drive continuous improvement in processes and evidence generation, and champion innovation and best practices to ensure Enovis remains a trusted, compliant, and evidence-driven leader in medical devices.

• 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…