About The Role
This role will be responsible for investigating, documenting and closing out customer complaints regarding medical device performance, ensuring compliance with FDA 21 CFR 820, ISO 13485, and MDR regulations. The ideal candidate will bring strong ability to analyze failure trends, perform risk assessments, and manage regulatory reporting to ensure post-market safety. Key duties involve root cause investigation, interacting with customers, and collaborating with engineering/quality teams.
What You'll Do
- Process complaints and regulatory (MDR, Vigilance, other) reports to ensure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner.
- Responsible for evaluating and processing complaints received by a client.
- Support complaint receiving and handling (documentation, coordination, investigation, resolution, and closeout)
- Check accuracy of complaint files at various points in the process
- Support with follow-up activities (e.g. additional information and product)
- Support complaint closure within Complaint Management System (CMS)
- Assess complaint events/files for reportability per client’s process and applicable regulations
- Initiate Medical Device Reports (MDR) for FDA submissions
- Complete MDR/vigilance reports per client process and regulations
- Regularly report to various levels of ECI/client management on the progress of Complaints and MDR.
- Interface directly with client’s internal and external customers and regulatory agencies as required.
- Additional items as discussed between client and ECI as determined reasonable will not require scope re-evaluation.
What We Look For
- Bachelor’s degree in engineering, biomedical engineering, or scientific field, or equivalent industry experience.
- 5-6 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device industry.
- Strong knowledge of FDA 21 CFR Part 820, 21 CFR Part 803 (MDR), and ISO 13485.
- Experience with QMS software and databases, plus the ability to read technical documents.
- Professional verbal and written communication skills to interact with clinicians and users.
- Excellent documentation skills for creating detailed investigation reports.
- Strong ability to analyze complex data to identify patterns.
