Analyst II, Quality Systems/Regulatory Compliance

- Mid Level

Princeton, NJ

About the position

CytoSorbents Corporation, 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 an Analyst II, Quality Systems/Regulatory Compliance to join our dynamic team in redefining the future of blood purification and help save lives worldwide! This is a hybrid position that requires a minimum of 3 days onsite.

Responsibilities

• Maintenance of Quality Management Systems to ensure conformity to ISO 13485:2016 and other applicable QMS requirements
• Ensure conformity with Post Market Surveillance requirements
• Support pre-market activities for various potential products
• Support Risk Management activities, including development of FMEA’s and generation and maintenance of Risk Management reports
• Managing/Maintaining the Customer Complaint process, including evaluation, investigation, escalation, and/or regulatory reporting
• Ensure documentation is completed in a timely fashion to meet regulatory requirements by working with internal product and clinical experts
• Develop, prepare, and analyze trend reports
• Maintain, update, and track regulatory requests - provide periodic status updates to open and closed requests
• Maintain regulatory files for product compliance, including 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
• Support and participate in QMS and product-related regulatory audits, serving as lead auditee, as required
• Conduct Corrective and Preventive action investigations/resolution as required
• Gather and present required information for Management Review
• Other duties as assigned

Requirements

• Bachelor’s degree in a technical field and 5+ years of supplier quality 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