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Regulatory Affairs Senior Consultant
POSITION SUMMARY: The Regulatory Affairs Associates will work with the Regulatory Affairs team providing professional support to our Representation and Importer clientele. MAJOR DUTIES AND RESPONSIBILITIES: Provide high-quality subject matter expertise and interpretations on applicable medical device regulations. Conduct regulatory reviews of Technical Documentation files Day-to-day activities associated with Post Market Surveillance (PMS) for our customer base: Reviewing and processing of serious incidents related of medical devices of customers. Supervision of field safety corrective actions performed by clients. Communication with competent authorities and clients. Addressing
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