Medical Call Center Supervisor

Are you a motivated leader with a keen eye for detail and a passion for ensuring medical device safety? We are seeking dedicated Supervisors to lead high-performing teams in a critical MDR Remediation project near North Chicago. This is a unique opportunity to contribute to life-changing regulatory efforts, gain valuable experience, and grow your career in a fast-paced, impactful environment.

Key Responsibilities:

• Lead and develop a team of 20-25 professionals across MDR screening, investigation, and submission functions.
• Drive execution of FDA 483 response activities, ensuring all tasks are compliant, timely, and audit-ready.
• Standardize workflows, manage performance, and provide ongoing coaching to maximize team efficiency.
• Oversee end-to-end MDR processes, including reportability assessment, data gathering, and submissions.
• Collaborate closely with cross-functional teams to resolve complex issues and prepare for audits and inspections.

Required Skills:

• Bachelor's degree in a scientific, engineering, or related field.
• At least 5 years of experience in medical device complaint handling, MDR reporting, or regulatory compliance.
• Minimum of 2 years of leadership experience managing teams of 20 or more.
• Strong knowledge of FDA regulations, especially 21 CFR Part 803.
• Excellent communication skills with proficiency in basic computer systems.

Nice to Have Skills:

• Experience with FDA eMDR submissions and complaint systems like ETQ Reliance or TrackWise.
• Familiarity with FDA coding, risk management, and CAPA procedures.
• Prior involvement with high-volume workflow management or remediation programs.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.