Clinical Regulatory Liaison

Career-defining. Life-changing.

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. 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 need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

iRhythm is currently seeking an experienced Clinical Regulatory Liaison who will support our Clinical Services Quality Assurance and process improvement.

This role is a hybrid position and you will be required to work in an iRhythm office (Deerfield, IL or Houston, TX two days per week).

Duties include, but are not limited to, clinical complaint review, investigation reports, adverse event reporting, complaints log and trend maintenance.

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

• 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

• 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.

#LI-JR1

Location:

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

As a part of our core values, we ensure an 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 taops@irhythmtech.com

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's 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.