Hiring: Complaint Vigilance Investigator II Company: Intuvie Location: Natick, MA Job Posted Time: 2026-09-10 11:58:34 About the job Experience: •2-4 years complaint handling experience required: Preferred in the FDA-regulated environment for Medical Device industry. •4 years complaint handling experience required: Preferred in the FDA-regulated environment for Medical Device industry. Required Skills: •Support process improvements to the complaint handling and MDR processes •Support metric and reports from the complaint handling system •Identifies potential concerns and escalates to management when necessary •Provides support of CAPAs and NC’s as necessary •Train to all assigned SOP’s, WI and templates/forms •Additional responsibilities may or may not be assigned to the employee; role assignment will be reviewed on a case-by-case basis determinant upon individual strengths, experience, knowledge, and expertise. •Associates degree or equivalent experience. Bachelor’s degree a plus •Minimum 2-4 years complaint handling experience required: Preferred in the FDA-regulated environment for Medical Device industry. Qualifications: •Review and analyze all feedback and assess if a complaint is alleged. •Triage customer feedback or questions and initiate complaints into the database. •Execute initial complaint review to ensure accurate codes are assigned, GFE are initiated, and intake has been properly performed. •Conduct thorough investigations into customer complaints, adhering to regulatory guidelines. •Perform final complaint review to ensure all requirements to investigate a complaint are met. •Provide feedback to improve Complaint and MDR processes. •Partner cross-functionally with Customer Service and Operations teams to facilitate the complaint handling process. •Reach out to the complainant to obtain missing information (GFE’s) needed for the complaint investigation and/or MDR processes. Provide customer response letters when requested. •Initiate and process MDR filings for the FDA, demonstrating a comprehensive understanding of regulatory requirements. Attend MDR review meetings for coding and narrative guidance on MDRs. •Document all stages of customer complaints, maintaining accurate records for compliance purposes. Compensation: •$70,000 - $80,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!