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Years of Experience
Date Last Verified
ProfileRegulatory Senior Managing/Principal Engineer The candidate's responsibilities for this position include: Manage and execute complex projects related to preclinical strategy and all phases of the FDA product review and approval process of medical devices in support of our clients; Active participation and leadership in our Biomedical Engineering Practice; Actively market the groups technical capabilities to clients and the scientific community; Develop additional expertise, gain additional industry exposure, and establish new and expanded client base through our unique technical consulting services; Attract and develop new projects and clients.
Qualification and Experience
The candidate should have M.D., J.D. degree, or M.S./Ph.D. in Bioengineering, Mechanical Engineering, Materials Engineering, Polymer Science or a related engineering field. Should have direct experience in a product development environment in medical devices is required, including working knowledge of medical device design control, Risk Management, MDR and FDA regulatory environments. Demonstrated experience in working with FDA and successful completion of 510(k) submissions and pre-IDE, IDE, PMA original submissions and subsequent revisions/supplements for medical devices. Should have 10+ years of professional experience, with 5+ years as a consultant. Outstanding verbal and written communication skills in order to effectively communicate highly technical issues to a non-technical audience while possessing the technical depth to collaborate with physicians and interact with regulatory bodies. Must be a recognized expert in field with a strong publication history. Established client relationships and a thriving consulting business is highly desirable. Testifying experience in trials and/or before government panels is an asset.