Analyst, Product Surveillance - Complaint Handling

Analyst, Product Surveillance III - Complaint Handling

Location: Alameda, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 5 months
• Pay Rate: $58.46 / Hour (USD)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

This role is focused on medical device complaint handling and post-market surveillance, requiring a seasoned professional who can independently evaluate, investigate, document, and close complex complaint records. The position demands deep expertise in regulatory requirements including 21 CFR Part 820, 21 CFR Part 803, ISO 13485, ISO 14971, and EU MDR, combined with strong data analytics capabilities to identify trends, detect emerging signals, and support data-driven quality and regulatory decisions. The hiring manager is specifically seeking candidates with direct complaint handling and post-market surveillance experience regulatory affairs experience with 510(k) submissions is not applicable to this role.

Key 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, regulatory requirements, and documentation standards.
• Support global vigilance reporting, adverse event reporting, and reportability assessments.
• Perform detailed quality reviews of complaint files to ensure compliance, documentation accuracy, consistency, and data integrity.
• Analyze large complaint and post-market surveillance datasets to identify trends, detect emerging product performance signals, support risk assessments, and drive data-based decision-making.
• Develop and maintain complaint metrics, dashboards, reporting tools, and visualizations to support Quality System monitoring, management review activities, regulatory compliance, and business objectives.
• Utilize SQL, databases, and analytical tools to extract, validate, trend, and interpret complaint data while ensuring data accuracy, completeness, and integrity.
• Support CAPA investigations, risk management activities, signal detection, and continuous improvement initiatives through data analysis and trend evaluation.
• Author, revise, and redline complaint handling procedures, work instructions, forms, templates, and training materials.
• Provide guidance, mentorship, and technical support to complaint evaluation and closure teams.
• Support regulatory inspections, internal audits, management reviews, and health authority inquiries.
• Collaborate with Regulatory Affairs, Medical Events, Engineering, Quality Compliance, Track & Trend, Data Analytics, Customer Service, and other cross-functional teams.
• Apply statistical and analytical methods to evaluate complaint trends, product performance data, surveillance indicators, and quality system metrics to support proactive quality improvements.
• Lead or support strategic post-market surveillance initiatives, process improvement efforts, and special projects.

Required Experience

• 5 8 years of medical device complaint handling or post-market surveillance experience.
• Demonstrated experience independently evaluating, investigating, documenting, and closing complex medical device complaints.
• Experience supporting adverse event reporting, complaint investigations, CAPA activities, complaint trending, risk assessments, and regulatory decision-making.
• Strong data analytics experience analyzing large and complex datasets to identify trends, detect emerging signals, assess risk, and support data-driven quality and regulatory decisions.
• Experience utilizing statistical analysis, data visualization, reporting methodologies, and analytical tools to evaluate complaint data, product performance, and post-market surveillance metrics.
• Experience working with SQL, databases, Salesforce, complaint handling systems, electronic quality management systems (eQMS), and business intelligence or reporting tools.
• Experience developing, maintaining, and interpreting quality metrics, dashboards, and performance reporting for management review and continuous improvement activities.

Required Skills

• 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.
• Advanced proficiency with Microsoft Excel, including pivot tables, advanced formulas, Power Query, data modeling, and data analysis techniques.
• Strong technical writing, documentation, communication, analytical thinking, data analysis, and problem-solving skills.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About the Client

This global healthcare innovator has dedicated more than 140 years to improving lives worldwide, with products reaching patients in more than 160 countries across medical devices, diagnostics, nutritional science, and pharmaceuticals. The organization's portfolio spans cardiovascular care, diabetes management, diagnostic testing, nutrition, and neuromodulation including groundbreaking continuous glucose monitoring technology, rapid diagnostic tests, minimally invasive cardiac devices, and nutritional solutions for patients across all life stages. Teams here include biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals, all contributing to healthcare breakthroughs that touch millions of lives. The organization is a certified Great Place to Work, with 80 percent of employees reporting it is a great place to work, well above the national average.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-16754

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