Quality Assurance and Regulatory Affairs professional specializing in creating, implementing and maintaining quality systems to provide sustainable compliance in the regulated medical device environment. Authored quality manuals and led departments in defining their Processes and Standard Operating Procedures. Proven record of accomplishment in certifying and recertifying companies to the Medical Device Directive (MDD), ISO 13485 and ISO 9001.
Developed regulatory strategies, managed and filed medical device submissions (Technical Files, 510k submissions, etc.) with regulatory agencies in Europe, the USA and other countries worldwide.
Prepared Drug Master Files (DMFs) and Device Master
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