Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.    Job #02548 About our client Our client is amongst the top servers of science and serves up to 35,000 customers in varied fields such as pharmaceutical and biotech companies, hospitals and clinical diagnostics labs, industrial process control settings, environmental settings, government agencies and also to universities and research institutes. The company has over 30,000 employees working for it in across 150 countries worldwide. They provide a complete range of high-end equipments, analytical instruments, reagents and consumables. They also provide software and services for research, analysis, discovery and diagnostics. Position Location Director of Regulatory Affairs Northern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Serve as the management representative to ensure that the quality management system is maintained and its efficiency is continuously improved 2) Develop, implement and improve the quality program to meet worldwide standards for efficiency, safety and quality 3) Plan, direct and develop ongoing interactions with regulatory agencies and OEM customers worldwide in matters related to obtaining regulatory clearance for product marketing 4) Develop strategies to obtain appropriate regulatory clearances 5) Assess the type and amount of product performance data required to ensure product approval 6) Work on extremely complex problems where analysis of situations or data requires an evaluation of intangible, variable factors 7) Exercise judgment in developing methods, techniques and evaluation criteria for obtaining results 8) Establish an effective quality management system to ensure that timely and appropriate actions are taken 9) Ensure that the quality requirements are satisfied and are consistent with the needs of the company’s business 10) Act as a liaison and interact with all regulatory agencies and auditors from OEM customers on matters related to quality system management 11) Coordinate and manage all corrective actions, including audit findings, customer complaints, non-conformance action (NCAR) and corrective and preventive action (CAPA) 12) Ensure timely, accurate and efficient management of quality assurance operation (including accurate document controls, up-to-date revision controls for product manufacturing, etc.) 13) Establish and manage effective employee training programs related to GMP, PCO, ISO regulatory requirements, EH&S-related requirements and NCAR and CAPA management 14) Provide leadership for the regulatory function and coordinate activities directed toward obtaining marketing clearance for all diagnostic products 15) Comply with Quality System Regulations (cGMP), ISO 9001, ISO 13485 and CMDR Regulations 16) Oversee and enforce company’s quality system 17) Develop and implement policies and procedures to comply with all government agencies’ regulatory requirement 18) Exercise full supervision in terms of budgeting, decision on costs, methods and employees in all functions necessary to satisfy the needs of the quality system 19) Make financial decisions on potential service contracts, material acquisition and capital equipment expenditures Requirements 1) BS, MS or Ph. D. 2) Minimum 10 years of IVD (product regulatory and compliance experience) 3) Hands-on experience in PMA clearance for IVD products 4) Experience in medical devices preferred 5) Experience in 510(k) and diagnostics 6) Experience in FDA, GMP, quality and leadership 7) Sound knowledge of all local, state, QSR and ISO regulatory requirements 8) High level of verbal, written communication and contract negotiation skills
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