Clinical Affairs Manager

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 In Vitro Diagnostic medical devices’ entire clinical evaluation process. The role will work through multiple levels within the organization and external stakeholders to influence and drive Waters Clinical Affairs strategy to support success of the Clinical organization. This role will report directly to the Senior Director, Quality, Regulatory and Clinical Affairs.

Strategic Activities:

• Subject Matter Expert in in all matters relating to clinical investigations, clinical evaluations, literature searches, and clinical affairs related regulatory requirements
• Determine and Develop clinical strategies in coordination with the management, the product managers, and the regulatory affairs managers fast, plannable, and cost-effective approval.
• help formulate the intended purpose/use and the “medical claims” in such a way that clinical data from predecessor or benchmark devices are used as effectively as possible, complex clinical investigations are avoided, or their scope is minimized, coordination within the company and with customers and authorities is optimized, and problems with approval, unnecessary costs, and delays are avoided as much as possible.
• Manage the necessary activities for clinical evaluations including planning, site evaluation, evidence compilation and evaluation and reporting.
• Research literature and evaluate information, including on the state of the art, on equivalent products, and on the safety and performance of their own and other devices and procedures.
• Execute clinical investigations in accordance with ISO 20916 and ISO 14155 (as applicable) and applicable ethical standards and legal requirements including formulating the study’s objectives, such as the clinical endpoints, plan the study, and commission and monitor Clinical Research Organizations (CROs) as required.
• Document the scientific output of studies and, if necessary, publish them.
• Monitor devices after market launch by conducting Post-Market Clinical Follow-up (PMCF) activities to collect and evaluate long-term safety and performance information.
• Perform systematic literature searches to determine probabilities of hazards and risks for the product in order to help identify new risks but also to update the frequencies of already known risks.

External Influence:

• Interact with clinical sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs) plus regulatory authorities as required to ensure timely, effective submissions of clinical evaluation documents.
• Manage relationship with clinical sites and IRBs/ECs, act as Waters representative.
• If needed, Manage relationship with Contract Research Organizations to complete clinical studies and FDA submissions on schedule and budget.
• Maintain up-to-date knowledge of global clinical requirements for all countries where product is planned for registration through regulatory intelligence activities.

• Minimum of an Advanced degree (Ph.D., M.S.) in a Life Science, MBA or equivalent.
• Proven extensive [+7yrs] regulatory affairs experience with medical devices, IVD experience essential.
• Extensive and proven understanding of FDA and EU clinical affairs regulations.
• Meet the qualification of an “evaluator” per MEDDEV 2.7/1.
• Experience with full clinical trial/evaluation lifecycle.
• Experience managing multiple clinical sites.
• Proven experience with the development of clinical affairs strategies.
• Proven knowledge of design and execution of clinical evaluation processes compliant to 21 CFR 50, 21 CFR 56, Declaration of Helsinki, the Common Rule, ISO 20916/ISO 14155 and IVDR.
• Desired - Prior experience in a leadership role with overall responsibility for managing a clinical affairs organization.     
• Strong ability to identify and analyse complex problems and recommend actions.
• Effective communication and influencing skills.
• Ability to mentor and develop individuals and teams.

 

 

Waters Corporation (NYSE:WAT) is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years. Our Company helps ensure the efficacy of medicines, the safety of food and the purity of water, and the quality and sustainability of products used every day. In over 100 countries, our 7,600+ passionate employees collaborate with customers in laboratories, manufacturing sites, and hospitals to accelerate the benefits of pioneering science. 

 

 

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.

Clinical Evaluations, Clinical Trials, Clinical Site Setup, Clinical Site Monitoring, Scientific Validity Report, SVR, Performance Evaluation Plan, PEP, Performance Evaluation Report, PER, Clinical Performance Study Plan, CPSP, Clinical Performance Study Report, CPSR, Close Out Visit, COV, Institutional Review Board, IRB, Informed Consent, IC, Ethics Committee, EC, Common Rule, ISO 14155, ISO 20916, 21 CFR 50, 21 CFR 56, 21 CFR 812, 21 CFR 809, MEDDEV, IVDR, Statistical Analysis Plan, SAP