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Regulatory Affairs Specialist job at Cortech, SKAN FALLS

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ESSENTIAL DUTIES AND RESPONSIBILITIES:
Other duties may be assigned
European Union MDD & MDR Reviews technical publications and revisions to standards to ensure compliance with regulatory and industry standards 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 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 distributors
Supports regulatory projects and OUS regulatory relations with Authorized Representatives and In Country Caretakers Reviews and approves sales and marketing literature to ensure regulatory compliance Assist with annual Regulatory activities (FDA Registration, Canadian Device Licenses, FURLS Listing, State Licenses, CFG) Assist with necessary registrations and licensing for new products and acquisitions • Supplies all regulatory agencies with requested information • 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 Supports regulatory audits
Perform labeling review and verification activities Participate in Risk Management and Post Market Surveillance as part of a cross-functional team
QUALITY AND REGULATORY REQUIREMENTS:
Quality System knowledge including the quality manual, quality policy, and applicable procedures and work instructions
Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulations, ISO 13485, EU MDD & MDR, Japanese Ministry of Health and Welfare, and Canadian Medical Devices Regulations
Completes and documents all required quality, business, and departmental training

Job country: United States

City: SKAN FALLS

Category: Regulatory Affairs Specialists

Location: Skan Falls, NY, United States

Job posted 2022-06-04

This job is expired

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