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Job Title: Instrument Compliance Specialist
Location: Durham, NC 27703
Duration: 1 Year with possible extension
Shift: Monday-Friday, 8 AM-5 PM
Pay: $50-$55
Description:
The position of Instrument Compliance Specialist within Diagnostics Regulatory Affairs will support global regulatory diagnostic and BioDevices with aspects of an assigned product portfolio associated with instrument compliance. This role will align with the company's business objectives and veterinary diagnostic and BioDevices 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 stakeholders, partner groups, suppliers, and customers.
Job Responsibilities:
Experience and Background:
Technical Skills Requirements:
Understanding of Machinery/diagnostics development process and regulatory requirements desirable.
Full Time
$65k-81k (estimate)
01/08/2024
05/30/2024