performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities. Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Conducts reviews of product and manufacturing changes for compliance with applicable regulations. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.
https://www.indeed.com/viewjob?t=regulatory+affairs+specialist+medical+devices&jk=49ee917eef7a931a&_ga=2.15383030.1395148856.1545000919-2077807285.1533320279
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