Senior Medical Device Post-Market Surveillance Analyst

Lancesoft; Alameda (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Lancesoft is seeking a Product Surveillance Analyst III in Alameda, CA to independently evaluate and close complex medical device complaints, supporting adverse event reporting and CAPA activities. You will work with cross-functional teams to analyze trends, maintain quality metrics, and drive data-driven decisions.

The role requires 5-8+ years of post-market surveillance experience, deep regulatory knowledge, and advanced Excel/SQL skills.

Qualifications

• 5-8+ years of medical device complaint handling or post-market surveillance experience.
• Strong knowledge of 21 CFR Part 820, Complaint Files (198), 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR, and medical device quality systems.
• Experience independently evaluating, investigating, documenting, and closing complex medical device complaints.
• Experience supporting adverse event reporting, complaint investigations, CAPA, trend analysis, and regulatory decision making.
• Advanced proficiency with Microsoft Excel (pivot tables, formulas, Power Query, data modeling).
• Experience with SQL, databases, Salesforce, eQMS, and BI/reporting tools.
• Developing, maintaining, and interpreting quality metrics, dashboards, and management reviews.

Responsibilities

• Independently evaluate, investigate, document, and close complex medical device complaint records.
• Serve as SME for complaint handling procedures, closure decisions, regulatory requirements, and documentation standards.
• Support global vigilance reporting, adverse event reporting, and reportability assessments.
• Perform detailed quality reviews of complaint files for compliance, accuracy, and data integrity.
• Analyze large complaint and PM surveillance datasets to identify trends and drive risk assessments.
• Develop and maintain complaint metrics, dashboards, and reporting tools for management reviews.
• Utilize SQL, databases, and analytical tools to extract and interpret data while ensuring data integrity.
• Support CAPA investigations, risk management, and trend evaluation.

Skills

Data analytics

Regulatory knowledge

Quality systems

Statistical analysis

Technical writing

Problem solving

Communication

SQL experience

Tools

SQL

Salesforce

eQMS

Power Query

Excel

Data visualization

Job description

Lancesoft is seeking a Product Surveillance Analyst III in Alameda, CA to independently evaluate and close complex medical device complaints, supporting adverse event reporting and CAPA activities. You will work with cross-functional teams to analyze trends, maintain quality metrics, and drive data-driven decisions.

The role requires 5-8+ years of post-market surveillance experience, deep regulatory knowledge, and advanced Excel/SQL skills.