Medical devices Vice President for Clinical and regulatory San Francisco Bay Area , company environments Ability , of Job We , stage and smaller

  • Published date: Feb 11, 2012
    • San Jose, United States
Medical devices Vice President for Clinical and regulatory San Francisco Bay Area  , company environments Ability , of Job We , stage and smaller

Company Description: Description of ___________________________ Job: We start medical device company that pioneered implant device for neurovascular applications. Summary of the position: Responsible for developing and implementing short-term and long-term global strategic and tactical plans to gain access to clinical and regulatory functions that are consistent with the objectives of the company's business in general. Basic functions: · Lead and manage the strategy and implementation of medical programs and to ensure regulatory approval of products and adopted at a meeting with corporate objectives within the regulations and guidelines. · Oversee the preparation and submission of all regulatory documents with the FDA and international regulatory bodies, and establishing standards and policies for company communications with regulators. · Interaction on a regular basis with the leadership of the company to ensure the harmonization of business objectives and that the company's performance to agreed targets. · Supervising a small team, and to identify and assign the appropriate talent to supplement the existing staff, and to identify and work with external suppliers to meet the performance requirements and the best timing. · Guide the development of practices, systems and processes to ensure continuous review of effective product design or manufacturing changes and adverse events · Guide the development of practices, systems and processes to ensure clinical operations efficient and effective, including the management of clinical trials, data analysis, and the final report of the study and publication. · Representing the business with regulators and medical professionals working in the field of clinical research with the company. · Develop and strengthen relationships with physicians celestial body, and representatives of regulatory and other key external parties. * Manage budget requirements and ensure compliance with the expenses to meet budget for the programs in all parts of the world. Executive Management: · Provide leadership and strategic vision, and direction, and implementation of research worldwide regulatory and clinical. • Develop a functional annual operating budgets for a household in the functions of clinical and regulatory long-term to meet the company's management objectives. · Recruit, hire, manage and develop a team of world-class clinical and organizational work force with a flexible start-up. Regulatory Affairs: • Develop a strategy for the clinical study and product approvals globally. · Direct regulatory processes to ensure high quality, timely reporting and compliance with international rules. · Manage and maintain the successful cooperation with representatives of the regulatory agency. • Develop regulatory measures and procedures to ensure ongoing review of the product design or manufacturing changes and adverse events Clinical Affairs: · Develop and implement strategies successfully a global clinical and implementation plans to achieve the strategic objectives of the company, including in particular, the development of treatment for the company and its products in target markets. • Provide strategic direction and scientific and operational activities for clinical trials of current and potential through the integration of design and preparation of the protocol, and conduct clinical and clinical monitoring, data management, statistics, study reports and regulatory activities related. Hands-on preparation and design and management of clinical trials and clinical studies for each of the past activities of the market and another for the market in all target markets. Qualifications required: · A minimum of the past ten (10) facing the medical device industry with apparent success in the development and implementation of clinical and regulatory activities. Q and ideally with experience of running a trial implant medical device through the regulatory approval. * The existence of respect for senior executives in clinical and regulatory medical device industry with an excellent working relationship and the experience of direct interaction with regulatory agencies, FDA and organizational units. · Proven ability to communicate with doctors key to "peer to peer" level. · A good understanding of the clinical evidence and the process of repayment. · Ideally have experience working with large public companies as well as in an early stage, and a smaller company environments. Ability and willingness to travel in the United States and globally nearly 10% of the time.

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