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Principal Regulatory Affairs Specialist

Company: Waters Corporation
Location: Milford
Posted on: March 19, 2023

Job Description:

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

  • Act as Subject Matter Expert (SME) and Regulatory Affairs lead for the new product development projects, provide "solution-based" advice to development teams
  • Proactively partner with R&D, Marketing, and other groups to develop and maintain regulatory and clinical strategies for new and modified product / product families, including expansion of scope of use and/or geographical areas
  • Prepare and execute regulatory filings such as pre-IDEs, premarket notifications, technical files, Canadian submissions, and letters to file.
  • Conduct international registrations in accordance with and in support of regulatory strategies
  • Provide input on and approve product labels and labelling including language requirements worldwide
  • Evaluate, set up and manage outside vendors such as License holders, Clinical Research organisations and In Country agents [including importers, distributors], as needed.
  • Perform regulatory research to find predicate and support new product development as needed

    Change Management

    • Provide regulatory guidance on changes to existing products
    • Monitor global regulatory intelligence, provide impact evaluation to changing regulations and mitigation approach option[s].
    • Performing regulatory impact assessments for engineering changes
    • Review and approve promotional materials, -
    • Oversee, maintain, and develop departmental policies, procedures and forms required to ensure compliance with applicable laws and regulations

      External Influence:

      • Act as the point of contact with Worldwide Competent Authorities, Notified Bodies and Authorized representatives
      • Interact with FDA and other global regulatory bodies plus registration authorities as required to ensure timely, effective submission
      • Manage relationship with international regulatory agencies and standard bodies, act as Waters representative providing input to application of existing regulations and proposed changes.
      • Maintain up-to-date knowledge of global regulatory requirements for all countries where product is registered for sale through regulatory intelligence activities

        Post Market

        • Provide regulatory input to support post market surveillance and vigilance activities
        • Support Health Hazard Assessments and Field Actions as needed


          • Participates in the implementation of Regulatory and Clinical Affairs strategy and accomplishes the key performance objectives.
          • Promote and generate a strong Quality culture within the Clinical Business Unit through effective collaboration with peers.
          • Act as Subject Matter Expert within 3rd party and internal audits
          • Mentor to regulatory specialists on regulatory and clinical affairs requirements and approach.
          • Ensure improvements are made in accordance with in accordance with the requirements of: ISO 9001; ISO 13485; 21 CFR parts 11 and 820.


            • Maintain the effectiveness of the Quality system at the sites via adherence to applicable policies and procedures
            • Complete Quality System related actions in a timely manner according to procedures e.g. CAPA, NCR
            • Adhere to Environmental, Health and Safety policies and procedures.

              Experience Required:

              • Minimum of a Bachelors Degree required, Analytical Chemistry, Biochemistry, or Biomedical Graduate education is preferable
              • Proven significant regulatory affairs experience in the In Vitro Diagnostic Medical Device environment supporting worldwide regulatory and clinical strategy for new and changed IVD medical devices
              • Proven experience with the development of multi-geography regulatory strategies
              • Proven experience and understanding of FDA and global regulations, including China, Europe (IVDR), India, and Brazil
              • First-hand experience with preparation and execution of regulatory filings such as pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval, preferably for clinical IVD products
              • Knowledge and application of ISO 9001, ISO 13485, ISO 14971, ISO 62304, 21 CFR 820, IVDR.
              • Experience reviewing clinical/performance evaluation reports and literature searches/reviews
              • Experience managing vendor selection and performance

                Experienced Preffered:

                • Desirable - knowledge and application of CLSI standards to assay validation
                • Desirable - knowledge of LC/MS and Software as a medical device (SaMD) regulations
                • Desirable - experience of regulatory filings in China, Australia, Canada


                  • Able to work effectively in a global function
                  • Ability to manage and influence in a complex, global matrix organization
                  • Strong ability to lead staff dispersed across many different locations and cultures
                  • Strong organization/prioritization skills
                  • Outstanding Work Ethic.
                  • Strong ability to identify and analyze complex problems and recommend actions.
                  • Effective communication and influencing skills.
                  • Strong team orientation and team builder with the ability to mentor and development members of the team
                  • Team player demonstrating good organizational and prioritization skills
                  • Self-starting demonstrating initiative

                    Company Description
                    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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