The Regulatory Affairs Specialist will provide regulatory guidance to study sponsors and IVD medical device manufacturers. You will be responsible for the overall planning and direction of clinical regulatory activities. In addition, you will develop and implement strategies in a collaborative environment between colleagues and clients with the goal of successful regulatory submissions. Responsibilities Lead project teams in support of Clients’ Regulatory and Clinical goals with the aim of bringing their products to market. Development, compilation, review and submission of U.S. Food and Drug Administration (FDA) Pre-Submission Meeting Submissions. Development, compilation, review and submission of Regulatory Filings such as FDA 510(k), de novo
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