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Manager Human Health Device Vigilance

Company: Zoetis, Inc.
Location: Kalamazoo
Posted on: November 22, 2020

Job Description:

Job Summary

The position of Human Health Device Vigilance Manager will lead the human health device vigilance program. Scope will include MDR reporting and management for Zoetis human health device products. Responsibilities include communication, owning deliverables and embracing priorities that align with the needs of Zoetis stakeholders and partner groups.

Responsibilities include but are not limited to:

Assist in the development of a human health medical device vigilance program.

Responsible for assisting in the maintenance of a human health medical device vigilance program, including but not limited to, ensuring potentially reportable incident /potential safety incident criteria is maintained.

Electronically process events to determine complaint and reportability status.

Complete electronic submission of MDRs to the FDA.

Review medical device reports (MDR) as required per internal policy & procedures and FDA regulations.

Collaborate with appropriate functional groups (Quality, Regulatory) to determine reporting eligibility.

Support internal systems, methods, and procedures to maintain compliance.

Assist in inspection support for FDA and global regulatory agencies. This may include research and preparation of correspondence in response to global regulatory agencies requests for additional information.

Develop and maintain a working knowledge of regulations and standards related to post-market quality & complaint handling.

Complete projects as assigned and required specific to post-market surveillance activities including quality and complaint handling.

Understands regulations related to human health medical devices on a global scale.

May assist in the production of worldwide vigilance reports in accordance with worldwide requirements and submits to appropriate regulatory agency within required timelines.

Works with Quality Assurance to properly escalate complaints in the quality management system.

Lead in the post market surveillance activities.

Basic Qualification:

Education Required: Bachelor's Degree in a scientific-related field and/or 5 to 10 years of relevant human health medical device vigilance experience.

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 zoetiscolleagueservices@zoetis.com 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 @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..

Keywords: Zoetis, Inc., Kalamazoo , Manager Human Health Device Vigilance, Healthcare , Kalamazoo, Michigan

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