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Diagnostics Regulatory Affairs Manager (JR00003584)

Zoetis

Last Updated: 9/22/20

Job Description

Zoetis is seeking a team player to fill the position of Regulatory Affairs Manager. The right candidate will bring advanced regulatory experience to our Global Diagnostics Regulatory Affairs team and will serve as a subject matter expert responsible for developing innovative pre-market regulatory affairs strategies for IVD hardware, software and consumables.

Job Duties Include but not limited to:

ᴑ Leader of 2-4 direct reports.

ᴑ Participate on product design teams by providing the regulatory strategy for new products or new claims for existing products.

ᴑ Assist in preparation of documentation needed for regulatory submissions.

ᴑ Serve as an alternate Liaison with USDA.

ᴑ Assure products compliance with Software, Firmware and Hardware Regulations.

ᴑ Provide support in review of label structure and content.

ᴑ Conduct risk assessments and review study reports

ᴑ Write and update technical files.

ᴑ Perform MDR evaluations and report adverse events.

Requirements:

  • BS/BA, MS in science, regulatory affairs or health related field
  • Strong in vitro diagnostics background
  • Understanding of enzymatic, immunoassay or organic chemistry helpful
  • System level experience in diagnostics or medical device development in an FDA regulated industry
  • Experience with 510(k)/CLIA requirements preferred
  • Systems orientation to product development
  • Familiarity/experience with manufacturing processes
  • Ability to establish goals and hold direct reports accountable to those goals
  • Demonstrated commitment to on time delivery and highest quality standards
  • Proficient in MS Office (especially Excel) and similar applications
  • 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.

Full time

Regular

Colleague

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. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [Register to View] to request an accommodation. 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 [Register to View] 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.



Company Details


Zoetis

Parsippany, New Jersey, United States

Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.