Clinical Regulatory Liaison
Clinical Regulatory Liaison
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Salary Not Disclosed
1 Vacancy
Job Description
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 careJoin Us Now!
At iRhythm we are dedicated selfmotivated and driven to do the right thing for our patients clinicians and coworkers. Our leadership is focused and committed to iRhythms employees and the mission of the company. We are better together embrace change and help one another. We are Thinking Bigger and Moving Faster.
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 iRhythms 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 regulatoryrelated duties as assigned
- Provide feedback regarding any systems or concerns to the Clinical Quality Manager
- Completeandpassallrequired trainingmodules
- 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
- 35 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 problemsolving skills
- Excellent written and verbal communication skills
- Detail oriented good organizational traits and selfmotivated
- Must be results oriented team player and able to work under minimum supervision
- Great work ethic and a desire to provide high quality outcomes
Whats in it for you:
This is a fulltime 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: NonExempt
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.
#LIJR1
Actual compensation may vary depending on jobrelated factors including knowledge skills experience and work location.
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. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.
iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures including those who may have any difficulty using our online system. If you need such an accommodation you may contact us at
About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect predict and prevent disease. Combining wearable biosensors and cloudbased data analytics with powerful proprietary algorithms iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care iRhythms vision is to deliver better data better insights and better health for all.
Make iRhythm your path forward. Zio the heart monitor that changed the game.
Employment Type
Full Time
