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Regulatory Affairs Manager
Develop, submit, maintain, and monitor standard operating procedures, policies, practices, and reports to assure compliance with all FDA and international medical device regulatory requirements and applicable standards. Primary Responsibilities: Prepares and evaluates regulatory documents and company specific SOP's, product manuals, Instructions for Use (IFUs), process flows and work instructions to maintain FDA QSR & ISO 13485 compliance. Prepares and assists in review and submission of regulatory submissions, product registrations and technical dossiers to FDA and EU Notified Bodies Audit and monitor internal processes and contract facilities for compliance with regulatory requirements, including FDA, CE, and ISO in applicatio


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