Complaint Handling Specialist (Medical Devices)

Location: United States

Salary: $66,000–$75,000 per year

Company

hirify.global is a medical technology company developing the iLet Bionic Pancreas and other type 1 diabetes management solutions.

What you will do

• Receive, document, triage, track, and close medical device complaints within required procedural and regulatory timelines.
• Coordinate complaint investigations by reviewing customer information, manufacturing records, device history records, product return evaluations, and related technical documentation.
• Support reportability assessments and prepare MDR, vigilance, and other regulatory reporting documentation when required.
• Work with Customer Care, Regulatory Affairs, Manufacturing, R&D, Clinical, and Quality Engineering on root cause analysis, risk assessment, and complaint closure.
• Escalate serious injury, death, hospitalization, product risk, recurring issues, and potential CAPA triggers.
• Support complaint trending, metrics, management reviews, audits, regulatory inspections, and continuous improvement activities.

Requirements

• 1–2+ years of experience in complaint handling, quality assurance, regulatory affairs, customer quality, or a related function in a regulated environment.
• Strong documentation, written communication, organization, time management, and follow-through skills.
• Ability to assess incomplete or ambiguous complaint information, identify high-risk cases, and manage deadlines in a regulated environment.
• Ability to collaborate cross-functionally and work independently while following quality and regulatory procedures.
• Proficiency with Microsoft Office, including Excel, Word, and Outlook.

Nice to have

• Bachelor’s degree in science, engineering, healthcare, or a related field, or equivalent experience.
• Experience in medical devices, pharmaceuticals, biotechnology, healthcare, or another FDA-regulated industry.
• Familiarity with FDA Quality System requirements, ISO 13485, MDR reporting, vigilance reporting, or post-market surveillance.
• Experience with quality management systems, complaint handling systems, CRM platforms, or electronic case management tools.
• Experience reviewing product return evaluations, manufacturing documentation, or device history records.

Culture & Benefits

• Mission-driven, collaborative culture with substantial ownership and impact.
• Comprehensive medical and dental coverage.
• FSA and HSA plan options, including an annual company HSA contribution.
• 401(k) program with employer match.
• Vacation accrual and paid holidays.