Vigilance Reporting Specialist

About the role

You will lead complex post‑market complaint and adverse‑event investigations from intake through closure, ensuring accurate records, timely resolution, regulatory compliance, and clear customer or internal responses.

Key responsibilities

• Lead complex complaint and adverse‑event investigations, including root cause analysis, documentation of findings, actions, and resolution.
• Analyze complaint data to identify trends, safety concerns, and product improvement opportunities.
• Ensure accurate complaint coding, coordinate new coding requests, and update records as information becomes available.
• Prepare and review customer and internal response letters, escalating complex matters for regulatory reporting when needed.
• Support training and qualification of new investigators on complaint handling processes and regulatory requirements.

Required profile

• Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or related field, or vocational education with at least 4 years relevant experience.
• Experience in medical devices, quality assurance, clinical research, or complaint management.
• Knowledge of post‑market surveillance, QMS, regulatory requirements, and CAPA methodologies.

Required skills

• Root cause analysis
• CAPA methodologies
• Data analysis
• Complaint coding
• Regulatory compliance

What we offer

• Salary range $63,000‑$88,200 annually (Nashville) or $67,000‑$92,600 (Plymouth, MN).
• Comprehensive benefits including PTO, 401k match up to 7%, HSA contributions, stock purchase plan, education reimbursement.