Instrument Compliance Specialist

Durham, England, United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Veterinary Health, Human Health, Medical DevicesIndustries

Requirements

Candidates should possess a Bachelor's degree in Business or Engineering, with a Master's degree preferred, and a minimum of seven years of demonstrated leadership responsibilities and deep industry knowledge of instrument compliance, including experience with regulatory requirements. Auditor and or Quality Engineering training is required, along with experience in IQ/OQ/PQ validations.

Responsibilities

The Instrument Compliance Specialist will serve as a liaison within Global Devices, Commercial, and GMS organizations to provide early compliance input into projects, conduct risk assessments, supply compliance support and advice for initiatives, provide input for inspections and audits, identify and interpret hardware safety/EMC standards, troubleshoot testing, schedule and facilitate instrument testing, coordinate factory inspections, support the risk analysis process, maintain product certification documentation, assess product construction and standard revisions, facilitate re-testing/re-certification, support Quality department with agency inspections, participate in product design discussions, evaluate design change controls, monitor and understand changes to compliance standards, and create and maintain technical files for veterinary diagnostics and support human health regulatory with instrument compliance aspects.