Senior Medical Device Post-Market Surveillance Analyst

Experis Technology Group; Alameda (CA); On-site; USD 76,000 - 83,000; Full time

Job summary

Experis Technology Group is seeking a Product Surveillance Analyst in Alameda, CA for a 6-month, onsite assignment. You will evaluate and close complex medical device complaints, support regulatory reporting, and analyze surveillance data to identify trends and risks.

The role requires 5–8+ years in post-market surveillance, strong regulatory knowledge, and advanced Excel/SQL skills. Collaboration with cross-functional teams and preparation of metrics will be key.

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.
• Strong data analytics skills with large datasets to identify trends and support decisions.
• Advanced proficiency with Excel (pivot tables, formulas, Power Query, data modeling).
• Experience with SQL, databases, Salesforce, eQMS, and BI/reporting tools.

Responsibilities

• Independently evaluate, investigate, document, and close complex medical device complaint records.
• Serve as SME for complaint handling procedures and regulatory requirements.
• Support global vigilance reporting, adverse event reporting, and reportability assessments.
• Perform quality reviews of complaint files for compliance and data integrity.
• Analyze large datasets to identify trends and drive data-driven decisions.
• Develop and maintain complaint metrics, dashboards, and reporting tools.

Skills

Data analytics

Regulatory knowledge

Problem solving

Documentation

Communication

Tools

SQL

Excel

eQMS

Salesforce

Power BI

Job description

Experis Technology Group is seeking a Product Surveillance Analyst in Alameda, CA for a 6-month, onsite assignment. You will evaluate and close complex medical device complaints, support regulatory reporting, and analyze surveillance data to identify trends and risks.

The role requires 5–8+ years in post-market surveillance, strong regulatory knowledge, and advanced Excel/SQL skills. Collaboration with cross-functional teams and preparation of metrics will be key.