Regulatory Affairs Specialist, International (IRC8566)

Details: The Regulatory Affairs Specialist prepares international submissions, regulatory correspondence and reports, and maintains a list of international product approvals based on U.S. and International requirements as defined in FDA Regulations, ISO 9001 Standards, ISO 13485:2003 Standard, European Medical Device Directives, Canadian Medical Device Regulations and other International Regulations. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: Prepares regulatory submissions according to country registration requirements to facilitate product approvals Maintains and updates list of international regulations and guidance documents, as required for the preparation of International submissions Coordinates the preparation of Certificates to Foreign Government, Certificates of Free Sale, and Declarations of Conformity as required for International registrations Tracks regulatory requests from International Distributors and maintains lists of product approvals Coordinates and tracks the notarization and legalization of regulatory documents Maintains database of International Distributor Authorization Letters Communicates with International Sales Managers and Distributors Participates in regulatory agency audits and responses to support audit findings or other actions related to such audits as needed Participates in training and education seminars as appropriate to learn international regulatory requirements Reads related regulatory publications and documents to stay informed about current regulatory actions Writes and updated departmental Standard Operating Procedures Performs other duties as required
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