Director, Risk Management And Complaints (Medtech)

TL;DR

Director, Risk Management and Complaints (Medtech): Leading global strategy and governance for risk management, complaint handling, and post-market surveillance of Class III implantable medical devices with an accent on regulatory compliance and system modernization. Focus on directing complex investigations, overseeing hazard analysis, and ensuring safety and efficacy across the product lifecycle.

Location: Remote (USA) with occasional travel to Cambridge, MA.

Salary: $178,000–$245,000

Company

A global biotechnology company dedicated to delivering life-changing medicines through excellence and innovation.

What you will do

• Lead global strategy and execution for risk management, vigilance, and post-market surveillance for Class III implantable devices.
• Develop and execute a strategic roadmap to modernize complaint management and surveillance systems.
• Oversee complaint intake, triage, investigation, and closure processes to ensure regulatory compliance.
• Direct complex product investigations in collaboration with engineering, manufacturing, and clinical stakeholders.
• Lead quality data analytics and signal detection using field performance data.
• Manage risk control effectiveness and hazard analysis throughout the product lifecycle.

Requirements

• Must be based in the USA.
• Bachelor’s degree required; advanced degree preferred.
• Minimum 12 years of experience in medical device quality systems risk management.
• At least 3 years of specific experience with Class III implantable medical devices.
• Proven experience with FDA Quality Management System Regulation and EU MDR requirements.
• Strong analytical skills and proficiency in quality data analytics.

Culture & Benefits

• Comprehensive medical, dental, vision, and life insurance plans.
• 401(k) program with company matching contributions.
• Generous paid time off including 15+ vacation days, end-of-year shutdown, and 12+ holidays.
• Paid maternity and parental leave.
• Tuition reimbursement up to $10,000 per year.
• Fitness and wellness programs with reimbursement.