Instrument Compliance Specialist
Zoetis

Role Description

The position of Instrument Compliance Specialist within Global Diagnostics Regulatory Affairs will support global regulatory diagnostic with aspects of an assigned product portfolio associated with instrument compliance. This role will align with Zoetis business objectives and veterinary diagnostic development projects, regulatory change management and/or routine regulation and compliance maintenance. Regulatory scope will include but is not limited to applicable instruments like analyzers, microscopes and centrifuges. Responsibilities include communication, interfacing between certification bodies during the development and maintenance process as well as working closely with the Quality, Regulatory, Commercial Development, Product Management and Engineering Departments throughout the product lifecycle, owning deliverables, and embracing priorities that align with the needs of Zoetis stakeholders, partner groups, suppliers, and customers.

Job Responsibilities:

• Participate in product design discussions/reviews to ensure product requirements are met for diagnostic products.
• Identify relevant product safety/compliance requirements for new designs and build appropriate regulatory strategy for project team implementation.
• Evaluate design change controls and identify applicable safety/compliance standards.
• Monitor and understand changes to compliance standards and communicate impact to marketed products as well as products in development.
• Working closely with certification bodies as primary contact in projects and life cycle maintenance

Experience and Background:

• Bachelor's Degree in engineering (e.g. electrical or machinery), alternative general science, chemistry, biology, etc. or equivalent
• Minimum 5 years' experience in field
• Knowledge of ISO/IEC standard requirements (e.g. IEC 61010-1 Safety Compliance)
• Familiarity with EU NLF (CE marking) and other EU Regulations
• Experience working in Quality Management System (e.g. ISO 9001) beneficial
• Strong working background in Design Control and Technical Documentation

Technical Skills Requirements:

• Understanding of medical devices/diagnostics development process and regulatory requirements desirable.

Full time

Regular

Colleague

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

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.

This job has expired.