What are the responsibilities and job description for the Complaint Handling & Risk Management Specialist position at Novozen Healthcare LLC?
Job title: Complaint Handling & Risk Management Specialist – Medical Devices
Job Summary
We are seeking a detail-oriented Complaint Handling & Risk Management Specialist to support post-market quality activities within a regulated medical device environment. This role is critical in ensuring product quality, patient safety, and compliance with global regulatory standards.
Key Responsibilities
- Review, document, and investigate product complaints in accordance with FDA and regulatory requirements
- Perform root cause analysis (RCA) and ensure timely complaint closure
- Assess reportability (MDR) and support regulatory submissions as needed
- Collaborate with Quality, Regulatory Affairs, R&D, and Manufacturing teams
- Support risk management activities including hazard analysis and risk file updates (ISO 14971)
- Identify trends in complaint data and drive CAPA initiatives
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other standards
- Maintain documentation and ensure audit readiness
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 5–7 years of experience in complaint handling (medical devices required)
- Strong knowledge of risk management (ISO 14971)
- Experience with MDR reporting and FDA regulations (21 CFR Part 820)
- Strong analytical, documentation, and problem-solving skills
- Excellent communication and cross-functional collaboration
Preferred Qualifications
- Experience with eQMS systems
- Knowledge of CAPA and post-market surveillance (PMS)
- Certifications such as ASQ, RAC are a plus