Senior Medical Safety and Complaints Specialist
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Career-defining. Life-changing.
At iRhythm youll 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 whats 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:
Why This Role Matters
In this role your clinical voice will shape safety narratives and elevate how we interpret and respond to real-world use of our cardiac monitoring technologies. Youll play a pivotal part in identifying trends safeguarding patients and influencing improvements to products that directly affect millions of patients every year.
What Youll Do
Lead Clinical Investigations: Provide expert clinical assessments of post-market complaints weaving together clinical product software and service aspects to determine potential safety risks and identify reportable events under global regulatory frameworks.
Ensure Regulatory Excellence: Assist with drafting and review of Medical Device Reports (MDRs) eMDRs and global vigilance reports (e.g. PDMA) with precision and clinical insight.
Interface with Stakeholders: Collaborate cross-functionally with QA RA Clinical Product and R&D teams to ensure a clinically accurate narrative of complaints driving investigations to clear resolution.
Trend and Triage: Identify patterns or emerging signals from post-market surveillance and support proactive safety strategies.
Coach and Educate: Serve as a clinical expert to train internal teams on complaint assessment workflows and medical rationale for reportability decisions.
Engage with the Field: Communicate with healthcare professionals patients and supporting teams to gather critical context and close the loop on safety-related concerns.
About You
Licensure & Background: RN with active license. BSN preferred. Clinical experience in cardiology or electrophysiology we are looking for clinical depth of knowledge.
Experience: 510 years in a clinical environment plus 3 years in medical device safety complaints handling or related post-market surveillance role.
Regulatory Fluency: Working knowledge of 21 CFR 803/820 ISO 13485 MEDDEV 2.12/1 and other global standards.
Communication Skills: Exceptional written and verbal communicationable to translate complex clinical scenarios into clear actionable insights for technical and regulatory audiences.
Analytical Mindset: Detail-oriented with strong critical thinking root cause analysis and deductive reasoning skills.
Ownership Mentality: You take initiative thrive in ambiguity and dont wait to be told what needs doingyou just do it.
Collaborative Spirit: You enjoy working across functions and value diverse perspectives when solving problems.
Youll Love This Role If You:
Are interested about using your clinical expertise in a broader way.
Are energized by working in a high-impact highly collaborative environment.
Want to be part of a company that values medical judgment as a key pillar of innovation.
Value being a part of a team which champions professional growth and autonomy.
Ready to make a difference where it truly matters
Apply now and help us continue to set the standard for cardiac monitoring.
Location:
Remote - USActual compensation may vary depending on job-related factors including knowledge skills experience and work location.
Estimated Pay Range
$91000.00 - $118000.00As 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
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 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.
There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page and all communications regarding the application interview and hiring process will come from a @ email address. Please check any communications to be sure they come directly from @ email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate please contact Written offers of employment will be extended in a formal offer letter from an @ email address ONLY.
For more information see and Experience:
Senior IC
Key Skills
- Microsoft Office
- Computer Skills
- Construction Experience
- Food Safety Experience
- Root cause Analysis
- Microsoft Powerpoint
- OSHA
- Child Protective Services
- EPA
- Unity
- EHS
- Manufacturing
