Product Analyst (Medical Devices) – Intellectt Inc

Job Description

Job Title: Product Analyst – Surveillance II

Location: Minnetonka, MN

Duration: 6 Months

Shift: 8:00 AM – 4:00 PM

Job Summary

The Product Analyst – Surveillance II is responsible for supporting post-market surveillance activities for medical devices. This includes evaluating adverse events, handling product complaints, and ensuring regulatory compliance through accurate reporting and analysis.

Key Responsibilities

• Perform various functions within the Post-Market Surveillance department
• Review, classify, and determine outcomes for:
• Adverse events
• Product complaints
• Assess seriousness, causality, and regulatory reportability of reported issues
• Prepare and submit Medical Device Reports (MDRs) to regulatory authorities, including FDA and international regions (e.g., Europe, Hong Kong)
• Manage product experience data and support complaint investigations
• Ensure compliance with regulatory standards and internal procedures

Required Skills & Experience

• 3–5 years of experience in:
• Post-market surveillance
• Medical device or pharmaceutical industry
• At least 1 year of experience with:
• FDA MDR reporting
• International (OUS) regulatory reporting
• Medical device lifecycle
• Regulatory requirements including:
• 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 198 (Complaint Files), 21 CFR Part 803 (Medical Device Reporting)
• Experience in complaint handling and investigation processes
• Proficiency in Microsoft Office Suite

Education Requirements

• Bachelor’s degree in Healthcare, Life Sciences, or a related field Or Associate degree with relevant experience in:
• Complaint handling
• Medical device reporting
• Product analysis

Preferred Qualifications

• Experience with MDR reporting for both:
• U.S. (FDA)
• International regions (e.g., Europe, Hong Kong)