Instrument Compliance Specialist

Role Description

Position Summary

The position of Instrument Compliance Specialist within Global Devices Regulatory Affairs will support global regulatory devices with aspects of an assigned product portfolio associated with instrument compliance. This role will align with Zoetis business objectives and veterinary/human health device development projects, regulatory change management and/or routine regulation and compliance maintenance. Regulatory scope will include but is not limited to applicable instruments like in ovo, in vivo, in vitro devices, 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.

Manages and assesses the safety, EMC, and quality compliance of instruments for the organization, coordinates the logistics for instrument testing at the laboratories, assists the manufacturing sites with scheduling inspections, and supports the risk analysis process of these products.

Essential Duties and Responsibilities

• Serve as a liaison within Global Devices, Commercial, and GMS organizations to provide early compliance input into early phase Discovery projects.
• Provide risk assessments for projects when applicable.
• Supply compliance support and advice regarding GMS/Commercial initiatives and market enhancements.
• Provides compliance input and appropriate follow-up for inspections, audits, and recall actions.
• Identifying and interpreting hardware safety/EMC standards for compliance,
• Troubleshooting with the compliance lab when tests are not going as expected (currently, only pulled in when needed, but could be more effective to have them manage the entire process)
• Scheduling and facilitation of testing of prototype instruments and final instruments
• Coordinating factory inspections with the GMS sites, based on product readiness
• Risk/Hazard analysis (currently process is undergoing updates with support of IC team members)
• Main point of contact with Certication body (i.e. TUV)
• Schedule and facilitate third-party testing
• Attend EMC testing for troubleshooting
• Review preliminary testing reports for accuracy, clarifications, etc.
• Review agency test reports and certifications, technical file packages
• Maintain and update product certification documentation
• Assess product construction revisions for compliance impact.
• Assess product standard revisions for compliance impact.
• Facilitate re-testing/re-certification for the above
• Support Quality department with agency inspections and findings (TUV / UL Factory Inspections)
• Participate in product design discussions/reviews to ensure product requirements are met for diagnostic products.
• Identify and communicate 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
• Create and maintain technical files for veterinary diagnostics and support human health regulatory with instrument compliance aspects within their technical files.

EDUCATION AND EXPERIENCE

• B.S. in Business or Engineering (M.S. preferred) or equivalent.
• Minimum of 7 years of demonstrated leadership responsibilities and deep industry knowledge of instrument compliance (regulatory)
• Auditor and or Quality Engineering training
• Demonstrated experience with IQ/OQ/PQ validations.

TECHNICAL SKILLS REQUIREMENTS

• Experience with control loop systems.
• Experience with drawing storage/control systems (EDM, EPDM, PLM, SAP, etc.)
• Experience with Engineering Change Management in Product Lifecycle Management (PLM) system.
• Demonstrated proficiency in creating engineering specifications and technical requirements.
• Experience auditing equipment, devices to international recognized standards to designs for safety/compliance of equipment (i.e., NRTL work, CE, IEC 61010, EN 55011, EN 60204)
• Experience in critical thinking and problem-solving skills, planning and organizing, decision-making.
• Familiar with and utilized root cause analysis techniques and documentation.
• Design for Six Sigma (DFSS) or Design, Reliability & Manufacturability (DRM)
• Knowledge of GD&T application
• Excellent communication skills, influencing and leading, facilitation and teamwork capabilities.
• Adept at data analysis and industrial statistics, using spreadsheets, MiniTab, Python, and SQL

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.