Job Description: Complaint Handling Specialist

Employment Type: Full-time

Position Overview

iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We are looking for builders, curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career.

Boldly innovating to create trusted solutions that detect, predict, and prevent disease. Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care. Join Us Now!

At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm’s employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.

Responsibilities

• Manage the end-to-end process of the complaint handling system.
• Review and verify the accuracy of complaint information.
• Triage complaints and determine required information needed to assess reportability decisions and conduct thorough product investigations.
• Follow established procedures to ensure timely and accurate execution and review of decision trees.
• Assist in drafting and submitting Medical Device Reports (MDRs), eMDR, and PDMA reports.
• Monitor and facilitate the timely reporting of MDRs and supplemental MDRs.
• Ensure compliance with iRhythm’s policies, procedures, and regulatory requirements.
• Route complaints to appropriate departments for further evaluation as needed.
• Interface and communicate with customers via phone, chat, and email when required.
• Provide training to personnel involved in the complaint handling process as directed by management.
• Identify missing critical information for follow up with customers and vendors for additional information or clarification.
• Engage with healthcare workers, consumers, and professionals regarding their quality concerns.
• Stay current on product knowledge and any updates to the complaint handling system.
• Maintain expert-level knowledge of the complaint handling system.
• Perform other duties as assigned.

Requirements

Experience:

• BA or BS degree in Science, Health Administration, Nursing, or related field (or equivalent combination of education and experience).
• RN license required.
• Minimum 5 years of experience in medical terminology, nursing, clinical or laboratory knowledge.
• Minimum 5 years of experience in complaint handling, the medical device industry, customer relations, complaint trending, and FDA/ISO regulations.

Knowledge and Skills:

• In-depth knowledge of Quality System standards and regulations, including 21 CFR 803 & 820, ISO 13485, and Canadian regulations.
• Strong understanding of product usage, including the ability to assess health risks to patients or healthcare workers.
• Experience working with customer system administrators and clinicians.
• Expert-level knowledge of complaint handling systems.
• Ability to work independently with minimal supervision, demonstrating ownership of tasks.
• Strong analytical, deductive reasoning, and listening skills.
• Excellent written and verbal communication skills with the ability to communicate precisely and accurately at all organizational levels.
• Strong interpersonal skills with the ability to build relationships.
• Ability to think creatively and provide innovative solutions to complex customer issues.
• Excellent time management and multitasking skills.
• Commitment to quality, customer service, and patient safety.

Additional Qualifications:

• Candidates should have a nursing background, ideally in cardiac care.

Company Information

At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions.