Clinical Regulatory Liaison

About this role:

iRhythm is currently seeking an experienced Clinical Regulatory Liaison who will support our Clinical Services Quality Assurance and process improvement. Duties include, but are not limited to, clinical complaint review, investigation reports, adverse event reporting, complaints log and trend maintenance. This role is a hybrid position and you will be required to work in an iRhythm office (Deerfield, IL Houston, TX or San Francisco, CA) 2 days/week.

Specific functions will include, but not be limited to the following:

• Support Clinical Service Quality through maintaining and enforcing iRhythm’s Clinical Quality Assurance System
• Review and evaluate clinical complaints related to misclassified rhythm, missed arrhythmia notifications and skin irritations to assist with clinical complaint investigation
• Assist with Clinical case review as part of the MDR process
• Assist in maintaining Clinical compliance with regulatory requirements regarding misclassified rhythms, missed arrhythmia notifications
• Assist with Regulatory remediation efforts, as needed
• Perform and/or coordinate clinical complaint investigations and gathering of additional information including contacting accounts and/or patients
• Perform frequent and timely review of MD Overread data and identify trends
• Assist with reconciliation of registration discrepancies
• Review and clinical investigation of tickets containing identified serious harm (hospitalization) or death
• Work closely with Clinical Operations and Regulatory to complete investigation reports
• Evaluate all information from a technical perspective to ensure appropriate analysis and investigation
• Review daily processes to ensure issues are being addressed and escalated in a timely manner
• Participate in process improvements
• Assist in Joint Commission preparedness and continuous compliance, ISO and CMS audits

• Perform other quality and regulatory-related duties as assigned
• Provide feedback regarding any systems or concerns to the Clinical Quality Manager
• Complete and pass all required training modules
• Maintain compliance with job specific proficiency requirements, including CCT certification (RN or Paramedic may qualify)
• Adherence to HIPAA Guidelines and Good Clinical Practices
• Other duties as assigned

About you:

• Associate degree or two years college course work preferred
• 3-5 years of experience in ECG monitoring or related field, with emphasis in cardiac rhythm interpretation (CCT, Holter Technician, Cardiac Rehab, RN, LPN, Paramedic with Critical Care Transport)
• Clinical or Regulatory Quality experience preferred
• Knowledge and familiarity with regulatory and complaint handling process
• Demonstrated capability in analyzing processes and identifying process improvement opportunities
• Current CCT certification and/or RN/Paramedic License or ability to be certified within 90 days of hire
• Knowledge of medical terminology specific to Cardiology
• Must have intermediate computer skills on MS Office software, Outlook and \Excel

• Must work across functional teams within the organization
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Detail oriented, good organizational traits and self-motivated
• Must be results oriented, team player and able to work under minimum supervision
• Great work ethic and a desire to provide high quality outcomes

What’s in it for you:

This is a full-time position with competitive salary package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off.

iRhythm also provides additional benefits including 401K (w/ company match), an Employee Stock Purchase Plan, annual organizational/cultural committee events and more!

FLSA Status: Non-Exempt

As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.

Make iRhythm your path forward.

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