Under general guidance, the Regulatory Submissions Specialist (R.S.S.) will create and assemble regulatory documents relating to the marketing and manufacture of medical devices. This includes the determination of information required to accompany product (labeling and product insert sheets). The R.S.S. will be responsible for regulatory documentation such as 510(k) submissions, regulatory and quality systems documentation requests from international distributors to support regulatory submissions and Notified Body submissions such as Notifications of Change as appropriate. Prepare regulatory submissions. Responsible for the creation and assemblage of technical documentation on the products, including EU Technical Dossiers and Clinical Evaluation Reports.
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