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Job #03463

About our client Our client is a publicly traded healthcare services company headquartered in Virginia with a 100-year track record of success in serving their customers. The company has an experienced management team and exceptional financial fundamentals, including recording both record revenue and earnings in 2008. This is a great situation for an executive that is interested in an opportunity to have a visible impact on a rapidly growing organization. Position Location Director of Compliance and Regulatory Affairs Louisville, KY Salary Highly competitive package, commensurate with experience Responsibilities 1) Demonstrated knowledge of design, development, and interpretation of regulatory action plans and strategies 2) Thorough understanding of regulatory, and legislative environments including knowledge of FDA regulations and cGMP regulatory compliance 3) Ability to independently identify compliance risks and either resolve or escalate when necessary 4) Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions 5) Able to communicate and train regulatory guidance to team 6) Manage, direct and monitor facility Quality Systems to achieve and maintain compliance with cGMP, ISO9001 2008, ISO 13485, and 21 CFR part 11, part 7- subpart C (Recalls), and part 820 (Quality System Regulation) 7) Provides direction into the build out and operations of the company's third party logistics business unit to comply with regulatory and operating requirements Requirements 1) A minimum of 10 years of healthcare industry experience in auditing and/or supply chain management compliance including 5+ years experience in supply chain strategy development, operations and project management 2) 5+ years of experience in hardware/software medical device development, regulations, standards, and current industry practices is required 3) cGMP regulatory compliance is required 4) Third party logistics experience is strongly preferred; international regulatory experience/exposure also preferred