Medical Device Compliance Specialist

About the role

This is a hybrid position based in Vernon Hills, IL. The work schedule requires working from home on Monday and Friday, and working in the office on Tuesday, Wednesday, and Thursday.

Responsibilities

• Complaint handling
• MDR reportability assessments
• Post-market surveillance
• CAPA support
• Audit readiness
• Risk-based documentation
• Cross-functional collaboration across Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders

Qualifications

• 1+ year of experience in complaint handling, MDR reportability assessments, post-market surveillance, CAPA support, audit readiness, risk-based documentation, and cross-functional collaboration across Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders
• Practical exposure to FDA medical device reporting expectations, 21 CFR Part 803, complaint-handling requirements, quality-system documentation, eMDR/FDA reporting workflows, regulatory decision rationale, and audit-ready records

Skills

• Strong technical writing
• Analytical thinking
• Attention to detail
• Prioritization
• Organization
• Documentation accuracy
• Project coordination
• Ability to manage multiple deadlines in a regulated environment
• Ability to interpret technical product information and translate it into regulatory decisions or documentation
• Microsoft Office / Excel / Word / PowerPoint
• Regulatory databases, tracking tools, complaint systems
• SAP, TrackWise, ETQ Reliance, RIMS/Veeva Vault, FDA eSTAR, ESG/eMDR workflows, and GUDID/UDI-related systems where applicable

Pay

The pay range for this position is $35.00 - $35.00/hr.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a hybrid position: Monday and Friday work from home; Tuesday, Wednesday, and Thursday work in the office.