Friday, January 26, 2018

Regulatory Specialist, Medical Devices Katalyst HLS


Job Description Job Description: Ensure compliance to local regulations and policies. Implement NPI & develop the regulatory submission plan. Support data analysis, mapping and migration activities from legacy systems Oversee preparation and review registration documents to ensure the submissions meet appropriate standard and content requirement. Interact with regulatory agency actively to expedite approval of pending application and to resolve regulatory matters. Provide regulatory affairs support during internal & external audit. Provide regulatory affairs support during internal & external audit.
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