Product Surveillance Analyst

Product Surveillance Analyst

Our client, the medical device and pharmaceutical industry, is seeking a Product Surveillance Analyst to join their team. As a Product Surveillance Analyst, you will be part of the post-market surveillance department supporting regulatory compliance and product safety initiatives. The ideal candidate will have strong analytical skills, attention to detail, and the ability to work independently and collaboratively within a team environment.

What's the Job?

• Determine classification, review, and disposition of adverse events and medically related complaints for on-market products
• Complete FDA Medical Device Reporting (MDR) and other international regulatory reports
• Manage product experiences by assessing seriousness, reportability, and potential causality of adverse events
• Send FDA medical reports to regulatory locations including Europe and Hong Kong
• Support multiple functions within the post-market surveillance department to ensure compliance and safety standards

What's Needed?

• 3-5 years of experience with complaints handling and MDR/MDV reporting preferred
• At least one year of MDR and OUS regulatory reporting experience required
• Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting
• Four-year degree in healthcare or science fields; or a 2-year degree with relevant experience
• Proficiency with MS Office Suite and the ability to work independently and as part of a team

What's in it for me?

• Potential to extend the contract based on performance
• Flexible working hours, including options to start earlier and finish earlier
• On-site work in Minnetonka, MN, with potential for one day remote work after training
• Opportunity to contribute to important safety and compliance initiatives in the medical device industry
• Collaborative work environment supporting professional growth and development

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay