Vice President Clinical Affairs

Position SummaryThe Vice President of Clinical Affairs is responsible for shaping and executing the global clinical strategy for FX Shoulder Solutions, a leading innovator in orthopedic devices specializing in shoulder arthroplasty. This role drives the design, oversight, and delivery of world-class clinical programs that support regulatory submissions, surgeon adoption, and long-term product success — from early feasibility through post-market follow-up.The VP, Clinical leads all aspects of clinical affairs including retrospective and prospective post-market surveillance studies, Medical Device Directive (MDD) and MDR (EU) compliance, and clinical input into regulatory strategy for global submissions such as FDA 510(k), CE Mark, and international registrations. This leader will build, mentor, and inspire a high-performing, multi-national team of clinical professionals to ensure FX maintains the highest standards of evidence generation and patient safety.Key ResponsibilitiesClinical Strategy & ExecutionDefine and implement the global clinical strategy supporting FX’s orthopedic portfolio, with emphasis on shoulder arthroplasty systems.Lead the design, approval, and execution of pre-market, post-market, and investigator-initiated clinical studies.Oversee IDE studies and retrospective and prospective post-market studies, ensuring robust data collection, analysis, and publication aligned with regulatory and business goals.Negotiate with potential study sites and interface with Investigational Review Boards to get approval for studies at selected sites.Build relationships with Investigators and their Research Assistants.Write clinical study protocols, interim reports, and final reports.Work with Investigators to get study results published in peer-reviewed journals.Maintain a library of published clinical articles and assist research clinicians with getting new articles published, especially those that support claims and marketing.Guide development of clinical evidence plans that demonstrate safety, performance, and real-world outcomes across international markets.Lead the creation and maintenance of clinical post-market surveillance (PMS) documentation as required by the EU-MDR including Clinical Evaluation Plans and Reports, Post-market Clinical Follow-up Plans and Reports, Literature Search Protocols and Reports, PMS Plans and Reports, Product Safety Update Reports, and Summaries of Safety and Clinical Performance.Regulatory & Compliance IntegrationPartner with Regulatory Affairs to support clinical components of 510(k), IDE, PMA, and international submissions (including EU MDR Technical Documentation and global equivalents).Ensure adherence to all global clinical regulatory requirementsOversee preparation and management of clinical documentation for audits, inspections, and notified body reviews.Leadership & Team DevelopmentLead, mentor, and expand a diverse, multi-national clinical team including managers, data specialists, and field clinical staff.Foster collaboration across R&D, Regulatory, Marketing, and Medical Education teams to align clinical initiatives with company objectives.Manage external clinical partners, CROs, key opinion leaders (KOLs), and surgeon investigators.Champion a culture of scientific rigor, transparency, and ethical conduct in all clinical operations.Recommend process changes for continuous improvement of clinical strategies, methods, and projects.Stakeholder EngagementDevelop strong relationships with orthopedic surgeons, clinical investigators, hospital systems, and regulatory agencies.Support publication strategy, congress presentations, and educational content derived from clinical outcomes.Serve as a key spokesperson for FX’s clinical excellence and innovation in the global orthopedic community.Operational OversightManage departmental budgets, resources, and timelines to ensure efficient and compliant study execution.Drive continuous improvement in clinical processes, systems, and technologies.Oversee internal and external audits of clinical practices and implement corrective and preventive actions as necessary.Qualifications & RequirementsBachelor’s degree required; advanced degree in life sciences, biomedical engineering, or related field strongly preferred.0+ years of progressive leadership experience in clinical affairs within the medical device industry, ideally in orthopedics or joint replacement.Proven success in developing and executing clinical strategies supporting 510(k), EU-MDR, and international regulatory submissions.Deep understanding of MDR, ISO 13485, and FDA post-market surveillance requirements.Demonstrated ability to lead multi-site and global clinical programs and manage cross-functional, multi-national teams.Experience interfacing with the FDA, notified bodies, and global regulatory authorities.Excellent leadership, organizational, and communication skills.Willingness to travel domestically and internationally (25%+).