Clinical Affairs Manager

Overview Key managerial position for Quality, Regulatory, and Clinical activities in support of the In Vitro Diagnostic Clinical business. The role will be responsible for planning, monitoring, and controlling the entire clinical evaluation process of In Vitro Diagnostic medical devices. The role will collaborate across multiple levels within the organization and with external stakeholders to influence and drive Waters Clinical Affairs strategy, supporting the success of the Clinical organization. This position reports directly to the Senior Director, Quality, Regulatory, and Clinical Affairs. Responsibilities: Strategic Activities: Serve as Subject Matter Expert in clinical investigations, evaluations, literature searches, and regulatory requirements related to clinical affairs. Develop clinical strategies in coordination with management, product managers, and regulatory affairs to ensure efficient and cost-effective approval processes. Assist in formulating the intended purpose/use and medical claims to optimize clinical data usage, minimize complex investigations, and streamline approval processes. Manage activities related to clinical evaluations, including planning, site evaluation, evidence collection, evaluation, and reporting. Conduct literature research and evaluate information on the state of the art, comparable products, safety, and performance. Execute clinical investigations in accordance with ISO 20916, ISO 14155, ethical standards, and legal requirements, including study planning and CRO management. Document scientific findings and publish results as necessary. Monitor device performance post-market through PMCF activities to gather long-term safety and performance data. Perform systematic literature reviews to assess hazards and risks associated with the product. External Influence: Engage with clinical sites, IRBs/ECs, and regulatory authorities to ensure timely submission of clinical evaluation documents. Manage relationships with clinical sites and IRBs/ECs, representing Waters. Coordinate with Contract Research Organizations to complete clinical studies and FDA submissions within schedule and budget. Stay informed on global clinical requirements through regulatory intelligence activities. Qualifications: Advanced degree (Ph.D., M.S.) in Life Sciences, MBA, or equivalent. At least 7 years of regulatory affairs experience with medical devices, specifically IVDs. Deep understanding of FDA and EU clinical regulations. Qualified evaluator per MEDDEV 2.7/1. Experience managing full clinical trial/evaluation lifecycle and multiple clinical sites. Proven ability to develop clinical strategies and ensure compliance with relevant standards (21 CFR, ISO, IVDR). Leadership experience in managing a clinical affairs organization is preferred. Strong analytical, communication, and mentoring skills. Waters Corporation, a global leader in analytical instruments, values diversity and is an equal opportunity employer. We consider all qualified applicants without regard to characteristics protected by law.

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