Senior Product Surveillance Analyst (Post-Market)

Experis (Austria); Alameda (CA); On-site; USD 69,000 - 76,000; Full time

Benefits offered by this job

Medical

Dental Plan

Vision Plan

401(k)

Weekly Pay

Job summary

Our client in Alameda, CA is seeking an Analyst, Product Surveillance III to join the Quality organization. The role focuses on supporting Product Surveillance and Complaint Handling, turning data into actionable post-market insights, and ensuring regulatory compliance.

The candidate should have 5+ years in post-market surveillance within the medical device industry, with onsite presence in Alameda. 6-month duration and pay range of $50-$55/hr on W-2 are offered.

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 activities, complaint trending, risk assessments, and regulatory decision making.
• Advanced proficiency with Microsoft Excel (pivot tables, advanced formulas, Power Query, data modeling) and experience with SQL, databases, Salesforce, complaint handling systems, eQMS, and BI/reporting tools.

Responsibilities

• Independently evaluate, investigate, document, and close complex medical device complaint records.
• Serve as a subject matter expert 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 to ensure compliance, documentation accuracy, consistency, and data integrity.
• Analyze large complaint and post-market surveillance datasets to identify trends and drive data-based decisions.

Skills

Complaint handling

Post-market surveillance

Data analysis

Excel (Pivot, formulas)

SQL

Salesforce

eQMS

Regulatory knowledge (21 CFR/IP)

Tools

SQL

Salesforce

eQMS

Power Query

Bi Tools

Job description

Our client in Alameda, CA is seeking an Analyst, Product Surveillance III to join the Quality organization. The role focuses on supporting Product Surveillance and Complaint Handling, turning data into actionable post-market insights, and ensuring regulatory compliance.

The candidate should have 5+ years in post-market surveillance within the medical device industry, with onsite presence in Alameda. 6-month duration and pay range of $50-$55/hr on W-2 are offered.