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Job #03288

About our client Our client is the world’s biggest medical device organization committed to less-invasive medicine. They lead the market in minimally-invasive medical devices delivering over 13,000 products to health professionals in close to fifty countries. These technologies offer alternatives to major surgery and other medical procedures that are typically traumatic to the body. The procedure usually involves inserting the device into the body through natural openings or small incisions and then guiding it to most areas of the anatomy to diagnose and treat a wide range of medical problems. Position Location Director of Regulatory Affairs San Jose, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee a group of product lines, technology and specialized functions 2) Identify, develop and implement strategic initiatives, franchise structure and management development 3) Establish and support a work environment of continuous improvement that supports the company’s quality policy, quality system and the appropriate regulations for the area they support 4) Ensure employees are trained to do their work and their training is documented 5) Direct and coordinate the Regulatory Affairs Department and related global submission activities 6) Establish departmental priorities to meet business objectives 7) Ensure that effective regulatory strategies are developed and implemented for new/modified devices to enable timely approval/market clearance/registrations in support of corporate goals and objectives 8) Ensure consistency and quality of submissions through technical guidance to the team during the course of strategy formulation and submission preparation 9) Manage relationships with local regulatory agencies and notified bodies 10) Ensure compliance with all relevant regulations and guidelines 11) Partner with Clinical Research to develop the most effective clinical trial strategies and protocols 12) Advise Divisional Management Team of prevailing and evolving global regulatory requirements and environment 13) Develop, implement and maintain departmental policies and procedures 14) Provide regulatory guidance to divisional MDR reporting function 15) Develop and manage departmental budget 16) Provide support to corporate regulatory device listing and establishment registration documentation as appropriate 17) Coordinate post-marketing approval activities 18) Foster employee career development 19) Participate in trade and professional organizations 20) Provide regulatory affairs training to Manufacturing and Development Teams 21) Foster relationships with business partners to ensure regulatory compliance 22) Provide regulatory support in new business development activities Requirements 1) Bachelor’s degree preferably in a scientific or technical discipline (advanced degree preferred) 2) Professional regulatory certification(s) preferred 3) Minimum 12 years of experience in regulatory affairs in the medical industry 4) 8+ years of recent managerial experience 5) Extensive understanding of FDA and global regulations 6) Background in developing regulatory submissions and documentation 7) Knowledge of clinical trial strategy and study designs with good working knowledge of statistical methods and data reporting 8) Understanding of relevant medical procedures, practice, terminology and products 9) Knowledge of product development process and design control 10) Excellent grasp of change control and test/validation requirements 11) Superb strategic, decision-making, communication (written and oral) skills 12) Excellent technical writing, editing, organizational, leadership, interpersonal, influencing and risk assessment skills 13) Ability to work on site 14) Willingness to travel (periodically)