Safety Analyst

Safety Regulatory Reporting Analyst – Healthcare

$35.00 per hour

Contract through November 2024

Monday-Friday 8:00am – 4:30pm

Plymouth, Minnesota – hybrid

The temporary position is responsible for managing device complaints and adverse events globally. This may include: complaint initial triage, submitting regulatory reports in accordance with applicable regulations, referring potential safety cases to applicable departments, providing updates to reports, reviewing for closure/reopening as needed, and assuring timely processing of complaints.

What you’ll be doing:

• Responsible for evaluating complaints from a patient safety perspective and completing regulatory reporting decisions per reporting requirements globally
• Responsible for creating and submitting regulatory reports to the FDA
• Works independently and is accountable for completing tasks as assigned
• Works well in a team to accomplish team goals

Who we’re looking for:

• Degree in Engineering, Medical Sciences, or other related scientific field required
• 2+ years of experience in a healthcare environment, and/or within a quality/compliance/regulatory org
• US FDA Medical Device Reporting and experience with Trackwise Digital preferred
• Managing device complaints and adverse events globally
• Experience with or knowledge of medical terminology and how medical/pharmaceutical products are typically used in a clinical setting
• Basic computer and software skills
• Must be able to communicate effectively with internal and external customers
• Demonstrate ability to collect, analyze, and interpret complaint and adverse event information