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Job #03546

About our client Our client is one of the world's leading medical device providers. They are highly profitable, publicly traded company whose products are currently being sold in over 120 countries worldwide. This is a great opportunity for someone to join a company which offers a great corporate culture and is focused on the long-term development of its employees. Position Location Director of RA/QA Michigan Salary Highly competitive package, commensurate with experience Responsibilities 1) Responsible for the selection, supervision, development and objective setting for teams consisting of managers and clerical/technical staff. 2) Works with the executive, regulatory affairs and quality assurance teams to achieve company's mission, vision and objectives. 3) Responsible for setting and achieving regulatory and quality goals and objectives. 4) Develops and maintains relationship with representatives of various regulatory agencies. Participates in audits and regulatory meetings as required. 5) Ensures that company is aware of all changes in legislation and regulation as applied to our business. 6) Regularly communicates department’s vision, quality goals and achievements to all employees as well as to senior staff on a regular basis. Communication may include, but is not limited to: business planning, business review, weekly meetings, etc. 7) Participates in interviews, sales meetings and customer site visits as requested. 8) Supports new business opportunities and acquisitions. Requirements 1) BA/BS degree in business or related discipline required. Master’s degree highly preferred. 2) Minimum of 6 years of proven leadership experience in a business environment (medical industry preferred). 3) Previous FDA experience highly preferred. 4) Must possess excellent communication, strategic thinking, analytical and negotiation skills. 5) Basic skills - Time management, project management, inter-personal, reports and budget, stress management, people management, conflict management, customer service, Windows, advanced computer, statistics, financial systems, ISO13485, FDA regulation, organization structure, and office equipment. 6) Functional skills – personnel selection, financial systems, organization structure protocol, interdepartmental interface, interdivisional interface and P&L management. 7) Expected to handle complex or difficult situations as appropriate. 8) Must possess valid driver license in the state of residence. 9) Meets cognitive demands to include visual discrimination/memory, auditory discrimination/memory reading ability, independent decision making and retention of specific knowledge