Principal Regulatory Affairs Specialist
Company: Waters Corporation
Posted on: March 19, 2023
The Principal Regulatory Affairs Specialist has primary responsibility for the determination and execution of In Vitro Diagnostic regulatory strategy including provision of regulatory input to new product development teams to ensure product requirements/design inputs, study design of pre-clinical/clinical trials and design outputs including assessment of clinical evidence enable identified planned regulatory filings.
Determine and execute regulatory strategy to expand scope of use and geographic registration of current Waters IVD portfolio.
Prepare, execute and maintain regulatory filings including change management, support of post market requirements and support of outside vendors [e.g. license holders, in country representatives].
This role reports to the Senior Director, Regulatory and Clinical Affairs.
The role will work through multiple levels and across functions within the Clinical Business Unit organization to support the growth of the IVD product portfolio.
New Product Development
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. -
Key WordsRegulatory, Specialist, Clinical, IVD, medical
Keywords: Waters Corporation, Milford , Principal Regulatory Affairs Specialist, Other , Milford, Connecticut
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