Job Details

Primary Job Title: Product Surveillance Analyst

Location: Minnetonka, MN, US

Onsite Flexibility: Hybrid

Contract Details:

• Position Type: Contract
• Start: As Soon As Possible
• Duration: 6 Months
• Pay rate: $33.82/hr
• Shift: 8AM - 4 PM

Job Summary: This Product Surveillance Analyst role performs multiple functions within the post-market surveillance department. Major responsibilities include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality. The position involves completing FDA MDR and other outside competent authority regulatory reports, as well as managing product experiences determining classification and disposition of adverse events and complaints for post-market products, with responsibilities including sending FDA medical reports to Regulatory locations in Europe and Hong Kong.

Key Responsibilities:

• Perform multiple functions within the post-market surveillance department
• Determine classification, review, and disposition of adverse events and medically related complaints for on-market products
• Make decisions on seriousness, reportability, and potential causality
• Complete FDA MDR and other outside competent authority regulatory reports
• Manage product experiences determining classification, disposition of adverse events, complaints for post-market products
• Send FDA medical reports to Regulatory locations (Europe and Hong Kong)

Education Requirements:

• Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis
• Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position

Required Experience:

• 3-5 years of experience with complaint handling and MDR/MDV reporting preferred; willing to consider 0-2 years of experience for the right candidate
• 1-year MDR for FDA and OUS (Europe/Hong Kong) experience is highly preferred
• 1 year of experience with MDR and OUS regulatory reporting experience required
• Knowledge of the use, development, and regulatory environment of medical devices
• Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, and Medical Device Reporting
• Related experience in post-market surveillance in the Medical Device or Pharmaceutical Industry

Required Skills:

• MS Suite Experience required
• Ability to work independently and as a team member
• Able to multitask
• Pay attention to detail

Benefit:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund

About the Company:
Global Healthcare Innovator
We're a leading healthcare company dedicated to improving lives worldwide. Our diverse portfolio includes medical devices, diagnostics, nutrition products, and branded generics. We're committed to developing groundbreaking technologies that address critical healthcare challenges and empower people to live healthier lives.
Join our team and:
Work on cutting-edge projects
Contribute to global healthcare advancements
Experience diverse cultures and geographies
Discover a rewarding career with a company that cares.

About GTT: GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-03354

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