Title: Analyst, Product Surveillance III Location: Alameda, CA Duration: 6 Months 100% Onsite Required Experience & Skills 5-8 years of medical device complaint handling or post-market surveillance experience. Strong working knowledge of 21 CFR Part 820, Complaint Files (198), 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR, and medical device quality systems. Demonstrated experience independently evaluating, investigating, and closing complex medical device complaints. Experience supporting adverse event reporting, complaint investigations, CAPA activities, complaint trending, and regulatory assessments. Strong data analysis skills with the ability to identify trends, assess risk, and support data-driven decisions. Advanced proficiency with Microsoft Excel and Microsoft Office Suite (Word, PowerPoint, Outlook). Experience working with SQL, Salesforce, complaint handling systems, and electronic quality management systems (eQMS). Strong technical writing, documentation, communication, and problem-solving skills. Primary Responsibilities Independently evaluate, investigate, document, and close complex medical device complaint records. Serve as a subject matter expert for complaint handling procedures, complaint closure decisions, and documentation requirements. Support global vigilance reporting and reportability assessments. Perform detailed quality reviews of complaint files to ensure compliance and data integrity. Analyze complaint data, identify trends, and support CAPA investigations, risk assessments, and continuous improvement initiatives. Develop and maintain complaint metrics, dashboards, and reporting to support business and quality objectives. Author, revise, and redline complaint handling procedures, work instructions, forms, and training materials. Provide guidance and mentorship to complaint evaluation and closure teams. Support regulatory inspections, internal audits, and health authority inquiries. Collaborate with Regulatory Affairs, Medical Events, Engineering, Quality Compliance, Track & Trend teams, and Customer Service functions. Support strategic post-market surveillance initiatives and special projects. Consultants Eligible Benefits Upon Waiting Period Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account (for High-Deductible Health Plans) Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) Supplemental Life Insurance Short Term Disability (coverage varies by state) Long Term Disability Critical Illness, Hospital coverage, Accident Insurance MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance 401(k) #J-18808-Ljbffr
Analyst, Product Surveillance III • Alameda, CA, United States
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