Medical Device Complaints & Regulatory Specialist

Spectrum Vascular; New Jersey; On-site; USD 65,000 - 90,000; Full time

Job summary

Spectrum Vascular seeks a Complaint Specialist to receive, document, investigate, and resolve product complaints in compliance with FDA QMSR, ISO 13485, EU MDR, and global requirements. You will work cross-functionally with Quality, Regulatory, Engineering, and CMOs to ensure timely resolution and continuous product improvement.

The role emphasizes regulatory reporting, trend analysis, and PMS activities, with a focus on maintaining confidentiality of complaint files and records.

Qualifications

• Bachelor's degree in a technical, scientific, or business-related discipline is preferred.
• 3 years related work experience as a complaint handler in the medical device industry.
• Knowledge of medical terms and Medical Device Reporting regulations.
• Exceptional organizational skills and attention to detail.
• Ability to perform job function with minimal supervision and work independently.

Responsibilities

• Ensure processing of complaints in a timely manner by coordinating and prioritizing investigations.
• Communicate with health care providers to acquire relevant complaint information.
• Enter product complaint information into the complaints database and assist in root cause investigations.
• Coordinate meetings, prepare minutes, and follow up on action items.
• Contribute to the development of complaint handling procedures and forms.
• Escalate issues to management and support CAPA activities as needed.
• Provide customer communication and status updates on complaint resolution.

Skills

Interpersonal Effectiveness

Communication

Collaboration & Teamwork

Prioritization

Technical Expertise

Continuous Improvement

Problem Solving & Prevention

Accountability

Education

Bachelor's degree in technical, scientific, or business-related discipline preferred

Job description

Spectrum Vascular seeks a Complaint Specialist to receive, document, investigate, and resolve product complaints in compliance with FDA QMSR, ISO 13485, EU MDR, and global requirements. You will work cross-functionally with Quality, Regulatory, Engineering, and CMOs to ensure timely resolution and continuous product improvement.

The role emphasizes regulatory reporting, trend analysis, and PMS activities, with a focus on maintaining confidentiality of complaint files and records.