Diagnostics Regulatory Affairs Specialist

Job Listing No: 9740000

Diagnostics Regulatory Affairs Specialist

Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.Our name, Zoetis (z-EH-tis), has its root in zo, familiar in words such as zoo and zoology and derived from zoetic, meaning “pertaining to life.” It signals our company”s dedication to supporting the veterinarians and livestock producers everywhere who raise and care for the farm and companion animals on which we all depend on.Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact.Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.Job Description:The position will support regulatory needs for the United States and will be responsible for ensuring diagnostic/medical device products comply with USDA CVB and FDA regulatory requirements. Job Duties Include but not limited to: Assist in preparation of documentation needed for regulatory submissions and other FDA and USDA license required documents. Support project team by providing the regulatory strategy for new products or new claims for existing products. Serve as an alternate Liaison with USDA. Assure products compliance with Software, Firmware and Hardware Regulations. Provide support in review of label structure and content. Conduct risk assessments and review study reports Requirements: * BS/BA, MS in science or health related field * Strong in vitro diagnostics background * Understanding of enzymatic, immunoassay or organic chemistry * System level experience in diagnostics or medical device development in an FDA regulated industry * Experience with 510(k)/CLIA requirements * If BS/BA 5+ years of experience; if MS, 3+ years of experience * Systems orientation to product development * Familiarity/experience with manufacturing processes * Participation in at least one development project through entire product life cycle (cradle to production) * Demonstrated commitment to on time delivery and highest quality standards * Strong production environment experience * Proficient in MS Office (especially Excel) and similar applications * Assist in interpreting and summarizing experiments * Basic math skills required * Ability to understand and carry out instructions furnished in written, oral, or diagram form * Ability to deal with problems involving several concrete variables in standardized situations * Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions. * Written Communication – Writes clearly and informatively; able to read and interpret written information. * Problem Solving – Identifies and resolves problems in a timely manner; uses reason even when dealing with emotional topics. * Planning/Organizing – Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.

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