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Clinically differentiated solutions that enhance patient outcomes and restore motion for life.
Senior Director, Clinical Affairs
Location
Switzerland
Posted
123 days ago
Salary
0
Seniority
Senior
Job Description
Senior Director, Clinical Affairs
Enovis
• 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.
Job Requirements
- 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.
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development opportunities
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