Senior Product Surveillance Analyst

Experis; Alameda (CA); On-site; USD 114,000 - 125,000; Full time

Job summary

Experis in Alameda, CA is seeking a Product Surveillance Analyst for a 6-month, 100% onsite assignment. You will lead complex medical device complaint investigations, ensure regulatory compliance, and support post-market surveillance initiatives.

The role requires 5-8+ years of experience in medical device oversight, strong data analytics, SQL, and proficiency with Excel. Collaboration with Regulatory Affairs, Quality, and Engineering is essential.

Qualifications

• 5-8+ years of medical device complaint handling or post-market surveillance.
• Strong knowledge of 21 CFR Part 820, 803 and ISO 13485/14971, EU MDR.
• Experience evaluating, documenting, and closing complex complaints.
• Proficient data analytics with large datasets to identify trends and risks.
• Advanced Excel skills and SQL/DB/CRM tools.

Responsibilities

• Independently evaluate, investigate, document, and close complex medical device complaints.
• Serve as SME for complaint handling procedures and regulatory requirements.
• Support global vigilance reporting and adverse event reporting.
• Perform quality reviews of complaint files for compliance.
• Analyze datasets to identify trends and drive risk assessments.
• Develop and maintain complaint metrics and dashboards.
• Utilize SQL and analytical tools to extract and interpret data.
• Support CAPA investigations and continuous improvement.
• Author and update procedures and training materials.
• Collaborate with cross-functional teams.
• Apply statistical methods to evaluate trends and quality metrics.
• Lead or support post-market surveillance initiatives.

Skills

Complaint handling

Regulatory knowledge

Data analytics

SQL

Excel (advanced)

eQMS

Quality metrics

Cross-functional

Technical writing

Tools

Salesforce

SQL databases

eQMS

BI tools

Job description

Experis in Alameda, CA is seeking a Product Surveillance Analyst for a 6-month, 100% onsite assignment. You will lead complex medical device complaint investigations, ensure regulatory compliance, and support post-market surveillance initiatives.

The role requires 5-8+ years of experience in medical device oversight, strong data analytics, SQL, and proficiency with Excel. Collaboration with Regulatory Affairs, Quality, and Engineering is essential.