Senior Medical Device Surveillance & Quality Analytics Lead

Collabera; Alameda (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

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 time

Paid holidays

Parental leave

Job summary

Collabera is seeking a Senior Product Surveillance Analyst to support medical device complaint handling, post-market surveillance, and regulatory compliance. The role focuses on data analytics, trend identification, and quality metrics to support product safety and continuous improvement.

The ideal candidate will investigate complex complaints, contribute to CAPA, and prepare management-ready dashboards. It requires strong regulatory knowledge and hands-on experience with eQMS, SQL, and Excel in

Qualifications

• 5–8+ years in medical device complaint handling or post-market surveillance.
• Strong knowledge of 21 CFR Part 820/803, ISO 13485, ISO 14971, EU MDR.
• Experience investigating complex complaints and documenting closure.
• Hands-on adverse event reporting, CAPA and regulatory assessments.
• Ability to analyze large datasets and identify trends.

Responsibilities

• Independently investigate and close complex medical device complaints per regulations.
• Serve as SME in complaint handling, regulatory compliance, and documentation standards.
• Support global vigilance reporting and regulatory reportability assessments.
• Review files for accuracy, completeness, and data integrity.
• Develop dashboards and data visualizations for management reviews.
• Use SQL, Excel, databases, and analytical tools to extract and interpret data.
• Contribute to CAPA investigations and risk assessments.
• Lead or support post-market surveillance initiatives and special projects.

Skills

Complaint handling

Regulatory compliance

Data analytics

Statistical analysis

Cross-functional collaboration

Mentorship

Problem solving

Documentation

Education

Bachelor's degree or higher in a related field

Tools

SQL

Microsoft Excel

databases

Salesforce

eQMS

Job description

Collabera is seeking a Senior Product Surveillance Analyst to support medical device complaint handling, post-market surveillance, and regulatory compliance. The role focuses on data analytics, trend identification, and quality metrics to support product safety and continuous improvement.

The ideal candidate will investigate complex complaints, contribute to CAPA, and prepare management-ready dashboards. It requires strong regulatory knowledge and hands-on experience with eQMS, SQL, and Excel in