Regulatory Affairs Specialist IV

Hi,ESSENTIAL DUTIES AND RESPONSIBILITIES: â Other duties may be assigned â ¢ European Union MDD & MDR â ¢ Reviews technical publications and revisions to standards to ensure compliance with regulatory and industry standards , will support FLC RA for EU MDR work.â ¢ Prepares and maintains Regulatory submissions for EU, US and rest of world (ROW) which may include STED Files, 510(k)s, Design Dossiers and similar submissions for ROW â ¢ Creates, maintains, and revises STED File/Design Dossier documentation to ensure compliance with current regulatory standards and product information â ¢ Supports international registration activities required by our customers or international distributors â ¢ Supports regulatory projects and OUS regulatory relations with Authorized Representatives and In Country Caretakers â ¢ Reviews and approves sales and marketing literature to ensure regulatory compliance â ¢ Assist with annual Regulatory activities (FDA Registration, Canadian Device Licenses, FURLS Listing, State Licenses, CFG) â ¢ Assist with necessary registrations and licensing for new products and acquisitions â ¢ Supplies all regulatory agencies with requested information â ¢ Assist 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 customer â ¢ Supports regulatory audits â ¢ Perform labeling review and verification activities â ¢ Participate in Risk Management and Post Market Surveillance as part of a cross-functional team