Medical Device Complaints Manager (Medtech)

TL;DR

Medical Device Complaints Manager (Medtech): Leading the design, execution, and continuous improvement of global medical device complaints and post-market surveillance processes with an accent on regulatory compliance and risk management. Focus on translating post-market signals into corrective actions, managing adverse event reporting, and ensuring audit-readiness for FDA and EU MDR standards.

Location: Must be based in the United States

Salary: $111,800 - $136,600 USD

Company

hirify.global is a global product design and technology company creating disruptive lifestyle solutions across multiple product categories.

What you will do

• Own and evolve global medical device complaints and post-market surveillance processes to ensure compliance with 21 CFR Part 820, ISO 13485, and EU MDR.
• Oversee the entire complaint lifecycle, including intake, triage, investigation, escalation, and closure across all regions.
• Lead adverse event assessments and vigilance reporting for FDA MDRs and EU MDR PMS/Vigilance.
• Establish and monitor complaint metrics and dashboards to identify systemic issues and emerging risks.
• Integrate complaints data into CAPA, risk management, and product improvement activities.
• Coordinate technical root cause analyses and lead medical device recalls and field actions.

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline.
• 7–10+ years of experience in medical device complaints handling, post-market surveillance, or quality systems.
• Proven experience operating processes compliant with 21 CFR Part 820 / FDA QMSR, ISO 13485, and EU MDR.
• Hands-on experience with adverse event reporting, vigilance submissions, and CAPA integration.
• Experience authoring EU MDR post-market documentation, including PMS plans and PSURs.
• Strong cross-functional communication skills to translate data into actionable product and risk decisions.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) retirement plan with matching and Health Savings Account (HSA) with company contribution.
• Employee stock purchase program and generous paid time off.
• Life insurance, AD&D, and short/long-term disability insurance.
• Additional perks: pet insurance, pre-paid legal insurance, identity theft protection, and product discounts.