Regulatory Affairs Analyst Ii

Overview The Regulatory Affairs Specialist II has primary responsibility for provision of In Vitro Diagnostic regulatory support to 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 Secondary responsibility would be to provide regulatory support to new product development teams to ensure product requirements design inputs and design outputs enable identified planned regulatory filings 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 Responsibilities Responsibilities Maintaining Sustaining regulatory filings Act as regulatory affairs lead for filing regulatory submissions for existing products for new geographies Develop and maintain regulatory strategies for new and modified product product families 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 Support set up and management of outside vendors such as License holders and In Country agents including importers distributors as needed New Product Development Act as Regulatory Affairs lead for the new product development projects provide solution-based advice to development teams Develop and maintain regulatory strategies for new and modified product product families Prepare and execute regulatory filings such as 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 Support set up and management of outside vendors such as License holders and In Country agents including importers distributors as needed Change Management Provide regulatory guidance on changes to existing products Monitor global regulatory intelligence provide impact evaluation to changing regulations Performing regulatory impact assessments for engineering changes Review and approve promotional materials Post Market Provide regulatory input to support post market surveillance and vigilance activities Support Health Hazard Assessments and Field Actions as needed Qualifications Education Bachelor s degree required preferably in Analytical Chemistry Biochemistry or Biomedical Engineering Graduate education is preferable Experience Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment or equivalent Knowledge and application of 21 CFR 820 and ISO 13485 is required Knowledge and application of the India and APAC specific IVD regulations is required First-hand experience with preparation and execution of regulatory filings such as premarket notifications licence applications technical files preferably for clinical IVD products Skills High fluency in English verbal and written Critical Thinking Active Listening and Technical Writing Skills Able to work effectively in a global function Strong ability to work with individuals teams dispersed across many different locations timezones and cultures US EU China India Australasia Strong organization prioritization skills Outstanding Work Ethic Effective communication and influencing skills Team player demonstrating good organizational and communication skills Self-starting demonstrating initiative Company Description 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