Associate Director, IVD Device Validation

Description

This position is part of a team that supports the analytical (non-clinical) studies for regulatory submissions of in vitro diagnostic (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.

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.