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.
ResponsibilitiesResponsibilities:
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 familiesConduct 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.New Product Development
Act 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 execute regulatory filings such as 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 Management
Provide regulatory guidance on changes to existing productsMonitor global regulatory intelligence, provide impact evaluation to changing regulations.Performing regulatory impact assessments for engineering changesReview and approve promotional materialsPost Market
Provide regulatory input to support post market surveillance and vigilance activitiesSupport Health Hazard Assessments and Field Actions as needed QualificationsEducation:
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 equivalentKnowledge and application of 21 CFR 820 and ISO 13485 is requiredKnowledge and application of the India and APAC specific IVD regulations is requiredFirst-hand experience with preparation and execution of regulatory filings such as premarket notifications, licence applications & technical files, preferably for clinical IVD productsSkills:
High fluency 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, timezones and cultures (US, EU, China, India, Australasia)Strong organization/prioritization skillsOutstanding Work Ethic.Effective communication and influencing skills.Team player demonstrating good organizational and communication skillsSelf-starting demonstrating initiative 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.
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