Associate Director, IVD Device Validation

2 months ago

Salt Lake City, United States BioFire Diagnostics, LLC Full time

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Description

This position is part of a team that supports the analytical (non-clinical) studies for regulatory submissions ofin vitrodiagnostic (IVD) products developed by bioMérieux. The Associate Director’s primary responsibility is to lead, direct, and/or advise teams responsible for the analytical validation studies that support global regulatory submissions and pre/post market support for bioMérieux’s IVD products. Please include a cover letter indicating your interest in and fit with the position. Essential Job Duties and Responsibilities Perform all work in compliance with company quality procedures and standards. Maintain current knowledge of regulatory requirements for establishing analytical performance of bioMérieux’s molecular IVD products. Participate in planning and execution of regulatory strategy for obtaining regulatory approval/clearance of bioMérieux’s molecular IVD products as it relates to analytical validation studies. Project resource, equipment, and financial requirements for short and long-term budgeting and strategic planning. Develop, monitor, and adjust project timelines, schedules, and resource allocation to achieve project, department, and company objectives. Ensure all studies, data, and documentation are designed, executed, and verified to a high standard and meet quality, scientific and regulatory requirements. Write, review, revise and/or approve project documents, study protocols and reports, and regulatory submissions documents in accordance with project timelines. Perform and advise on the hiring of personnel (scientist, research associate, etc.) and maintain staffing requirements to meet projects goals and timelines. Ensure all training requirements are met and create opportunities for personnel development and progression. Identify and alleviate gaps in technical, scientific, regulatory, and management knowledge/skills needed for high quality personal and team performance. Collaborate with directors, scientists, and others in various company departments to report and resolve technical issues and/or develop new products. Facilitate the bi-directional dissemination of technical and strategic information as well as significant company/department progress, challenges, objectives, and training requirements. Develop content for new product training for sales, marketing, and customer support teams. Ensure product expertise for ongoing product support of internal and customer-facing inquiries and post-market surveillance. Make contributions to literature, conferences, grant/proposal writing, and patent applications. Performs other duties as assigned.


Qualifications:

Education and Experience PhD in a scientific discipline or equivalent At least five years of experience working in a regulated industry, preferably IVD At least three years of experience managing personnel and functional teams. Knowledge, Skills, and Abilities Strong written and verbal communication skills Strong leadership and time management skills Working knowledge of regulations applicable to molecular IVDs, as they pertain to analytical validation studies.

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