Senior Product Surveillance Analyst -Medical Device

Job Title: Senior Product Surveillance Analyst – Medical Devices

Location: Alameda, CA 94502

Duration: Contract (Approximately 12 Months)

Work Type: Onsite

Job Summary:

We are seeking an experienced Senior Product Surveillance Analyst to support medical device complaint handling, post-market surveillance, regulatory compliance, and quality data analytics for a leading healthcare technology organization. The ideal candidate will have extensive experience investigating complex medical device complaints, assessing regulatory reportability, analyzing complaint trends, and developing quality dashboards to support product safety, risk management, and continuous improvement.

Key Responsibilities:

• Independently evaluate, investigate, document, and close complex medical device complaints in accordance with regulatory and quality requirements.

• Serve as a subject matter expert in complaint handling, complaint closure, regulatory compliance, and documentation standards.

• Support global vigilance reporting, adverse event reporting, and regulatory reportability assessments.

• Review complaint files to ensure documentation accuracy, consistency, completeness, and data integrity.

• Analyze large complaint and post-market surveillance datasets to identify trends, emerging safety signals, and product performance issues.

• Develop and maintain quality metrics, dashboards, reporting tools, and data visualizations to support management reviews and regulatory compliance.

• Utilize SQL, Microsoft Excel, databases, and analytical tools to extract, validate, analyze, and interpret complaint data.

• Support Corrective and Preventive Action (CAPA) investigations, risk assessments, signal detection, and continuous improvement initiatives.

• Author, revise, and maintain complaint handling procedures, work instructions, forms, templates, and training materials.

• Provide technical guidance, mentorship, and support to complaint investigation and closure teams.

• Support regulatory inspections, internal audits, management reviews, and health authority inquiries.

• Collaborate with Regulatory Affairs, Engineering, Quality Compliance, Medical Events, Data Analytics, and other cross-functional teams.

• Apply statistical analysis and data trending methodologies to evaluate product performance and quality system metrics.

• Lead or support post-market surveillance initiatives, quality improvement activities, and special projects.

Required Qualifications:

• 5–8 years of experience in medical device complaint handling, post-market surveillance, or related medical device quality functions.

• Strong working knowledge of 21 CFR Part 820, 21 CFR Part 803, ISO 13485, ISO 14971, and EU MDR.

• Demonstrated experience independently investigating, evaluating, documenting, and closing complex medical device complaints.

• Hands-on experience with adverse event reporting, complaint investigations, CAPA, complaint trending, and regulatory reportability assessments.

• Strong analytical skills with experience evaluating large datasets, identifying trends, detecting emerging signals, and supporting risk-based decisions.

• Experience applying statistical analysis, data visualization, and reporting methodologies to complaint and post-market surveillance data.

• Advanced proficiency in Microsoft Excel, including pivot tables, advanced formulas, Power Query, data modeling, and data analysis.

• Experience with SQL, databases, Salesforce, complaint management systems, and electronic Quality Management Systems (eQMS).

• Experience developing quality metrics, dashboards, performance reports, and management review materials.

• Strong technical writing, documentation, communication, analytical thinking, and problem-solving skills.

• Ability to work independently, manage complex investigations, and collaborate effectively with cross-functional teams.

Preferred Qualifications:

• Experience supporting medical device complaint handling within a regulated medical device manufacturing environment.

• Familiarity with FDA Medical Device Reporting (MDR), global vigilance requirements, and post-market regulatory reporting.

• Experience with business intelligence tools, dashboard development, and quality performance reporting.

• Experience supporting regulatory inspections, quality audits, and health authority inquiries.

• Experience mentoring complaint handling teams and contributing to quality process improvements.

• Experience with complaint signal detection, product risk management, and statistical trend analysis.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $40/hr to $50/hr