Regulatory Affairs Specialist IV

ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned Performs regulatory assessment on all customer complaints Performs MDR and Vigilance evaluations and completes filings as required Reviews technical publications and revisions to standards to ensure compliance with regulatory and industry standards Prepares and maintains Regulatory submissions for US and OUS which may include 510(k), STED Files, Design Dossiers and similar submissions for ROW (Rest of World) Creates, maintains, and revises STED File/Design Dossier documentation to ensure compliance with current regulatory standards and product information Supports international registration activities required by our customers or international distributorsSupports regulatory projects and OUS regulatory relations with Authorized Representatives and In Country CaretakersReviews and approves sales and marketing literature to ensure regulatory complianceAssist with annual Regulatory activities (FDA Registration, Canadian Device Licenses, FURLS Listing, State Licenses, CFG)Assist with necessary registrations and licensing for new products and acquisitionsSupplies all regulatory agencies with requested informationAssist with customer relations for QA/RA which may include but is not limited to: o Ensures customers receive any required quality documentation and product related information o Completion of customer surveys and responding to the customerSupports regulatory auditsPerform labeling review and verification activitiesParticipate in Risk Management and Post Market Surveillance as part of a cross-functional teamQUALITY AND REGULATORY REQUIREMENTS:Quality System knowledge including the quality manual, quality policy, and applicable procedures and work instructionsEstablish, implement, and maintain the quality system in accordance to FDA Quality System Regulations, ISO 13485, European Union Medical Device Directives, Japanese Ministry of Health and Welfare, and Canadian Medical Device Regulations