Apply Description CytoSorbents Corporation (NASDAQ: CTSO), as a leader in the treatment of life-threatening conditions through the use of innovative blood purification solutions, is dedicated to advancing medical technology by developing safe, effective and reliable devices that empower healthcare providers and transform patient care. We are seeking a Senior Analyst, Quality Systems/Regulatory Compliance to join our dynamic team in redefining the future of blood purification and help save lives worldwide! Responsibilities: * Maintenance of Quality Management Systems to ensure conformity to ISO 13485:2016 (MDSAP) and other applicable QMS requirements. * Maintain regulatory compliance requirements, including support during regulatory audits. * Acts as a Subject Matter Expert for external audits and inspections by external regulatory authorities. * Liaise between the Company and the various regulatory agencies. Interfaces directly with US FDA, Authorized Representatives, Notified Bodies, Competent Authorities, and Auditing Agencies. * Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. * Provide interpretation of regulatory authorities' feedback, policies and guidelines. * Assist in preparation and tendering of regulatory submissions to health agencies. * Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures. * Provides regulatory assessment for Quality Management System, manufacturing, and design changes. * Reviews and advises on labeling, product claims, marketing brochures, advertising and promotional material and other publications to ensure compliance with regulations. * Ensure conformity with Post Market Surveillance requirements. * Support pre-market activities for various potential products. * Risk Management activities, including development of FMEA's and generation and maintenance of Risk Management reports. * Customer Complaint process, including: Evaluation, investigation, escalation and/or regulatory reporting. * Documentation being completed in a timely fashion to meet regulatory requirements by working with internal product and clinical experts. Development, preparation, and analysis of trend reports * Maintain, update and track regulatory requests - provide periodic status updates to open and closed requests * Maintain regulatory files for product compliance Includes creation/maintenance of Technical Documentation (EU) and other comprehensive files to meet regulatory requirements * Manage/Maintain the Supplier Quality program - travel (up to 15%) required for performance of supplier audits (including international locations) * Communicate results with worldwide customer support personnel as well as other internal departments * Leads the internal audit program and leads/performs internal audits in accordance with the corporate harmonized policies, processes, procedures, internal procedures, and relevant standards/regulations. * Conduct Corrective and Preventive action investigations/resolution as required * Gather and present required information for Management Review * Creates, reviews and approves document/engineering change requests. * Other duties as assigned Requirements * Bachelor's degree in a technical field and 8+ years of QMS/Regulatory experience in a regulated industry * Experience with handling non-conformances and corrective actions * Experience with medical device risk management activities * Experience with Corrective and Preventive Action activities, including investigation and closure * Experience with processing medical device Customer Complaints * Experience performing ISO compliant auditing and reporting * Ability to apply critical thinking and problem-solving skills and to work collaboratively to find the best solution * Strong writing, time management and communication skills Salary Description $115k-$120k