Requirements:PA
Education: Bachelor’s Degree (BS or BA), preferably in a technical discipline, life sciences field or related discipline.
Knowledge: Comprehensive knowledge of U.S. FDA regulations relating to (510(k)s, PMAs and the review of promotional and labeling materials. Demonstrated ability to develop an advanced technical knowledge of a company’s products and their clinical application. Although this position does not require the candidate to personally develop statistical plan, the candidate must be able to understand the statistical plan and communicate with biostatisticians.
Experience: Minimum of five years experience in regulatory affairs addressing (510(k)s, preIDEs, IDEs, PMAs and PMA Supplements. Experience in the development of clinical protocols: identification of patient population, clinical end points, study work flow, etc. The ideal candidate will have knowledge of MRMC (Multi-Reader/Multi-Case) studies.
Travel: Position will require domestic and international travel approximately 3 days per month domestically and international travel approximately twice per year (5-10 days).
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