The In Vitro Diagnostic complaint handling specialist is responsible for receiving, documenting, evaluating, and investigating product complaints in compliance with regulatory requirements (e.g., FDA 21 CFR Part 820/ISO 13485, CAP/CLIA, ISO 15189, NYSDOH). This role ensures timely and accurate complaint processing, supports product quality improvement, and helps maintain patient safety and regulatory compliance.
location: Durham, North Carolina
job type: Contract
salary: $75 - 90 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- ?Review, document, and process customer complaints related to IVD products.
- Perform initial assessments to determine complaint validity, severity, and reportability (e.g., MDR, vigilance reporting).
- Conduct or support complaint investigations, including root cause analysis and trend evaluation.
- Collaborate with cross-functional teams (Quality, Regulatory, R&D, Manufacturing, Clinical Laboratory, Medical Affairs, Safety, Engineering, Supply Chain) to resolve complaints.
- Ensure all complaint records are complete, accurate, and compliant with internal procedures and regulatory requirements.
- Identify and escalate potential product safety issues or adverse events.
- Support regulatory reporting activities (e.g., FDA MDR submissions, EU vigilance reporting).
- Maintain complaint handling databases and ensure timely closure of records.
- Analyze complaint trends and provide input for CAPA (Corrective and Preventive Actions).
- Participate in audits and inspections by regulatory authorities and notified bodies.
- Contribute to continuous improvement of complaint handling processes and quality systems.
qualifications:
- Bachelor's degree in Life Sciences, Biomedical Engineering, Quality, or a related field.
- 5+ years of experience in complaint handling, quality assurance, or regulatory affairs in the medical device or regulated industry.
- Strong knowledge of FDA regulations (21 CFR Part 803) and ISO 13485.
- Familiarity with MDR reporting requirements and global vigilance systems.
skills: Corrective and Preventive Actions (CAPA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
