Customer Compliance Specialist

Employment Type

: Full-Time


: Miscellaneous

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BioFire Diagnostics, LLC. is looking for a Customer Compliance Specialist to join our growing team! The Customer Compliance Specialist will assist BioFire customers in ensuring they are in compliance with regulatory and accrediting agencies (e.g. FDA, CAP, CLIA, MDR regulatory bodies, etc.) with regards to BioFire Products. They will assist the customer in understanding matters related to the verification or validation of BioFire products within their laboratory. They will ensure the customer has all relevant information to allow them to identify compliance gaps and make necessary process improvements. They will assist the customer in understanding any audit findings or deficiencies and make suggestions on process changes to bring the customer into regulatory compliance. This position requires a strong understanding of the global regulatory landscape. Essential Job Duties and Responsibilities: * Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics' Quality System. * Provide regulatory compliance technical expertise and guidance to BioFire Diagnostics customers * Aid BioFire Diagnostics customers with questions about verification and/ or IQCP * Collaborates with customers and regulatory authorities to develop positive and proactive approaches to regulatory compliance and inspection readiness * Recommends strategies for ensuring compliance to changes of applicable medical device regulatory standards * Keep current with all internal procedures, as well as changes in all relevant regulatory guidelines and subsequent standards * Tracks BioFire customer regulatory audit findings, and other similar complaints, and identifies trends * Documents and properly trends all customer interaction with BioFire's CRM * Attend regular internal meetings regarding customer regulatory compliance, or other meetings as needed Supplemental Information: * Up to 40% domestic travel may be required * Some after hours or on call work may be required * Ability to lift and maneuver up to 40 lbs safely Training and Education: Bachelor's degree in biological science or related area is required. Master's degree in a biological science or related field is preferred but not required. ASCP certification preferred but not required. Experience: 5+ years' experience in a laboratory compliance role within a CAP-accredited and CLIA certified laboratory setting. Knowledge, Skills and Abilities: Excellent communication skills, both written and verbal. Must be able to interact with people of all scientific levels, such as clinical laboratory technicians, safety officers, managers, supervisors and directors; Ph.D. scientists; associate professors; CAP and FDA regulators and inspectors; key opinion leaders (KOL); clinical product managers; researchers; hospital administrators; medical engineers; and physicians. Being bilingual is preferred but not required.

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