Senior Regulatory Affairs Specialist
ATR International
Job Info
<b>Job Description:</b><br><br> We are seeking a Senior Regulatory Affairs Specialist for a very important client <br><br>Duties: This position will be working with multiple business units to develop, update, and improve regulatory affair processes Assist the strategy implementation and operations for regulatory affairs activities, product registration submission, progress reports, supplements, amendments, or periodic experience reports Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR Identify opportunity for regulatory affair processes and drive changes to completion.<br><br><b>Requirement:</b><br><br>Years Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs <br><br>Skills: Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessment in Have working knowledge in US and EU medical device submissions Have experience supporting internal and external inspections Work cross-functionally and in a matrixed environment Have experience with continuous improvement activities <br><br>Education: BA Degree Required<br>#PandoPandoLogic. Keywords: Regulatory Compliance Specialist, Location: Temecula, CA - 92593
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