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Job #03120

About our client Our client is a global leading developer and manufacturer of medical diagnostic instrument and reagent systems. They focus on providing leading-edge automation technology for use in slide-based diagnosis of cancer and infectious disease. With their 40-acre campus HQ based in Tuscan, AZ, our client boasts a financial and intellectual capital to partner successfully with the healthcare community. Their products are found in hospital-based histology laboratories, independent reference laboratories and the drug discovery laboratories of some of the world’s largest pharmaceutical and biotechnology companies, government labs and medical research centers. This is an exciting opportunity for the right person to join a world leader. Position Location Vice President, Quality and Regulatory Affairs Tuscon, Arizona Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure the overall development, implementation and coordination of quality systems, regulatory strategies and activities 2) Provide effective people leadership and development for a staff of 25 – 30 3) Function as the Company Management Representative as well as the Senior Quality and Regulatory contact and strategist with the FDA, CMS, international regulatory agencies, notified bodies and other regulatory bodies 4) Establish, communicate, implement and maintain the vision and strategy for the company's quality system 5) Translate quality and regulatory requirements into terms understood by the business and process owners 6) Utilize influence and respect to gain the support of the cross-functional business function leaders 7) Ensure that the company quality system is compliant, effective and efficient 8) Provide compliant quality and regulatory strategies to support, encourage and deliver innovative ideas from proof of concept through end of product life with consistent focus on customer satisfaction and expectations 9) Support new ideas with scientific documentation of proof of design, regulatory strategy, regulatory approval, proof of manufacturability, etc. to communicate the customer’s experience with the company's products and services 10) Provide direction and development of the Quality and Regulatory Team 11) Ensure that the team provides review, day-to-day management and operational success for all quality and regulatory functions including the successful integration of activities (cross-functionally) 12) Monitor the US and international regulatory environments 13) Provide the executive management with assessments of the impact of new and changing regulations on the company's business 14) Collaborate on quality issues to develop, coordinate, prepare and maintain international medical device submissions such as EU design dossiers and technical files and Canadian submissions 15) Develop and implement training programs for direct reports and other functional groups to ensure awareness of all requirements and maintain compliance with all current regulations 16) Coordinate the review and approval of product labeling and advertising 17) Review marketing promotional materials and provide leadership/guidance in developing compliant sales training, advertising and detail literature 18) Maintain the regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to management 19) Review and approve company policies and procedures for the company quality system 20) Develop and manage capital and operating budgets for the quality and regulatory department 21) Perform other duties as required or assigned Requirements 1) Bachelor's degree in Business, Sciences, Engineering or a related field (Master's degree preferred) 2) 10 – 15 years of progressively responsible quality systems and regulatory management experience (medical device industry) 3) Proven experience in negotiating with regulatory agencies including experience in filing of 510ks, PMAs and IDEs 4) International regulatory experience an asset 5) Hands-on experience as well as scientific and technical background/training in regulatory submissions for in-vitro diagnostic devices 6) Working knowledge of medical device development process as well as European, US and international regulations, laws and standards (in-vitro medical devices) 7) Successful track record of working in a matrixed organization and building strong partnerships with other organizations including R&D, manufacturing, clinical affairs and other senior management 8) In-depth knowledge of FDA and ICH regulations and requirements 9) Superb leadership and team development skills 10) Ability to understand, interpret and explain complex device development details and regulations to non-experts 11) Ability to lead discussions with Executive Management Team on strategy and policy issues 12) Ability to organize, negotiate and lead the team in strategic discussions with regulatory agencies