Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable
Details:
Looking for an Adverse Event Specialist to review and process new product complaints in a high-volume environment.
This individual will read and evaluate complaint narratives, determine reportability based on established procedures and regulatory requirements, and document findings accurately within the complaint management system.
The specialist will be responsible for managing approximately 50–60 complaints per day while maintaining quality, compliance, and productivity standards.
Must Haves:
- 3–5 years of experience in complaint handling, adverse event processing, or a related quality/regulatory function
- Hands-on experience with MDR reporting, including knowledge of 21 CFR Part 803 and completion/submission of FDA Form 3500A
- Experience reviewing new complaints and determining reportability
- Ability to analyze and interpret complaint narratives and supporting documentation
- Experience working in a high-volume environment, processing 50–60+ complaints per day
- Experience working within regulated healthcare, pharmaceutical, or medical device environments
