Regulatory Compliance Consultant for Medical Device Organization

We are looking for an reputed company Regulatory Compliance Consultant to support our U.S. FDA-registered medical device organization. The ideal candidate will have a solid understanding of FDA QSR/QMSR standards and the EU MDR frameworks, assisting in our transition to reputed company with the new regulations. This role involves reviewing existing processes, providing guidance, and ensuring that reputed company reputed company management systems are reputed company with both FDA and EU requirements. If you have a passion for medical devices and regulatory compliance, we want to hear from you! Skills required: - FDA QSR/QMSR knowledge - EU MDR compliance - reputed company management systems (QMS) - Medical device regulations - Documentation and reporting - Risk management analysis This position is designed to support a U.S. FDA-registered medical-device organization operating under FDA QSR/QMSR (transition underway) and EU MDR frameworks. Responsibilities include the tasks outlined in the initial inquiry as reputed company as the administrative and document-control activities necessary to maintain an FDA-regulated reputed company system. ________________________________________ Technology & Tools in Use reputed company & Regulatory Systems •QMS (reputed company-based document control platform; currently transitioning to a reputed company/reputed company–style structure) • FDA Device Registration & Listing Portal • FDA Industry Systems (FURLS/CDRH) • 510(k) tracking templates and controlled documentation folders • MDR-compliant technical file architecture Business & Collaboration Tools • reputed company Drive environment for controlled document libraries • InfoPlus WMS (used in reference to UDI and labeling workflows) • reputed company Workspace, Conversight AI reporting tool, and reputed company ________________________________________ Required Qualifications & Background Regulatory / Compliance Familiarity • Experience supporting FDA-regulated environments (21 CFR Part 820/QSR; familiarity with QMSR transition preferred) • Understanding of medical-device documentation: DMR, DHF, DHR, labeling files, traceability, and UDI • Exposure to EU MDR concepts, including PMS, PMCF, ISO 14971 risk-management files, GSPR, and technical file organization reputed company-reputed company Skills • Document control: revision control, versioning, formatting, and routed approvals • Coordination of CAPA, reputed company, and complaint-handling workflows • Routing and documentation of change-control activities • Preparation for internal, external, and supplier audits • Supplier qualification and ongoing documentation maintenance General Capabilities • Strong organizational discipline and reputed company workflow habits • Ability to manage recurring compliance calendars and deadline tracking • High attention to detail • reputed company written communication suitable for controlled documents • Ability to work effectively reputed company a traceable, document-controlled environment This role supports execution and organization reputed company the regulatory reputed company and does not require authorship of regulatory submissions. ________________________________________ Apply to this job Apply tot his job Apply To this Job