OverviewWaters is looking for a Regulatory Affairs professional to work through multiple levels and across functions within the Clinical Business Unit organization to support the growth of the IVD product portfolio.Provide In Vitro Diagnostic regulatory support to new product development teams to ensure product requirements/design inputs and design outputs enable identified planned regulatory filings.Prepare, implement, and maintain regulatory filings, including change management, supporting post-market requirements and supporting outside vendors (e.g. license holders, in-country representatives).ResponsibilitiesNew Product DevelopmentAct as Regulatory Affairs lead for the new product development projects, provide "solution-based" advice to development teamsDevelop and maintain regulatory strategies for new and modified product/product familiesPrepare and implement regulatory filings, including technical files, Canadian submissions, and letters to file.Conduct international registrations in accordance with and in support of regulatory strategiesProvide input on and approve product labels and labelling, including language requirements worldwideSupport set up and management of outside vendors such as License holders and In Country agents (including importers, distributors), as needed.Change ManagementProvide regulatory guidance on changes to existing productsSupervise global regulatory intelligence and provide impact evaluation of changing regulations.Performing regulatory impact assessments for engineering changesReview and approve promotional materialsPost MarketProvide regulatory input to support post-market surveillance and vigilance activitiesSupport Health Hazard Assessments and Field Actions as neededLeadershipSupport generating a strong Quality culture within the Clinical Business Unit through effective collaboration with peers.Act as Subject Matter Expert within 3rd party and internal auditsManage and maintain Regulatory Affairs internal policies and proceduresProvide guidance to regulatory specialists as needed to support regulatory and/or clinical strategy requirements.QualificationsEducation:A bachelor's degree or equivalent experience is required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education or equivalent experience is preferred.Experience:Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalentKnowledge and application of 21 CFR 820 and ISO 13485 is requiredKnowledge and application of the European IVD regulations is required, IVDR preferredFirst-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 productsDesirable – experience of regulatory filings in China, Australia, Canada and APACProficiencies:High proficiency in English, verbal and writtenCritical Thinking, Active Listening, and Technical Writing SkillsAble to work effectively in a global functionStrong ability to work with individuals/teams dispersed across many different locations and culturesStrong organization/prioritization skillsOutstanding Work Ethic.Effective communication and influencing skills.Supportive team member exhibiting excellent organizational and communication competenciesSelf-starting, demonstrating initiativeTravel (If Applicable):Dedication to a minimum of 60% in-person/office, including an average of 2 travel trips annually Company DescriptionWaters 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.