Director - Regulatory and Clinical Affairs

Company: Waters
Location: Raynham
Posted on: June 15, 2022

Job Description:

Key leadership position for Regulatory and Clinical activities in support of the In Vitro Diagnostic Clinical business. The role will be responsible to work through multiple levels within the organization to influence and driving Waters Regulatory & Clinical Affairs strategy to support Waters business growth and success. Ensures all Regulatory and Clinical documentation is for global registration and maintained throughout the product life cycle. This role will report directly to the Vice President, Quality Assurance, Regulatory Affairs and Clinical Affairs. - This role leads a Global team of Regulatory Affairs professionals with Clinical Affairs activities included as part of the Waters Clinical Business Unit. - Strategic Activities: - - -Lead the Global Regulatory & Clinical Affairs function for Waters Corporation, with emphasis on global strategy for in vitro diagnostic clinical business activities - - -Monitor trends and changes in regulations and advise internal stakeholders on the potential impact to current and future strategy and tactics - - Provide strategy and review for clinical study protocols, labeling, and integrated summary documents based on risk and all unique country requirements - - Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on the market globally - - -Develop and implement regulatory and clinical policies and procedures aligned with the overall company strategy and targeted to meet desired risk as a business. - - Core Activities: - - Direct day to day regulatory affairs activities, including reviewing promotional materials, participating in submissions and interaction with regulatory agencies - - -Oversee the process of preparing product submissions and registrations to domestic and international regulatory bodies, managing the process from inception to approval - - Assess regulatory impact of post-market changes on labeling, promotional materials, design, materials, manufacturing process, or packaging. - - -Consult with and manage external regulatory affairs consultants. - - -Maintain compliance with FDA and global medical device regulations - External Influence: - - -Interact with FDA and other global regulatory bodies as required to ensure - - timely, effective submissions - - -Manage relationship with international regulatory agencies - - -Maintain up-to-date knowledge of global regulatory requirements for all countries where product is registered for sale through regulatory intelligence activities - Other Responsibilities: - - -Participate in due diligence and integration activities of domestic or foreign acquisitions that have regulatory implications - - -Participate in external audits with Clinical or Regulatory questions or reviews - - -Ensure regulatory and clinical review of Health Hazard Assessments and support of field actions - - -Train, mentor and supervise regulatory and clinical employees, consultants and contractors. maintaining high ethical standards, positive team spirit and strong participative leadership. - - Master's degree required preferably in science, engineering or business. - - - -15+ years regulatory affairs experience with medical devices. IVD experience a must. - - -Extensive understanding of FDA and global regulations, including China, Europe (IVDR), India, and Brazil - - 7+ years managerial experience - - Experience in establishing, developing, and maintaining relationships with government authorities and regulatory agencies - - - -Experience with the development of global regulatory strategies - - -Ability to manage and influence within a global matrix organization - - -Highly developed intercultural competence/awareness - - - Strong team orientation and team builder with the ability to mentor and development members of the team - - Effective communication and influencing skill - - - - Operates with integrity and, transparency - - -Acts as a true company owner to advance the overall interests of Waters - - -Carries a broad global perspective of markets, tech, and trends - - -Balances clear strategic thinking and accountability in execution to deliver results - - - - - - - - - - - - - - - - - - #LI-CB1 - - - Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality. - - - Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We're the problem solvers and innovators that aren't afraid to take risks to transform the world of human health and well-being. We're all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow. - - - - Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.

Keywords: Waters, Brockton , Director - Regulatory and Clinical Affairs, Executive , Raynham, Massachusetts