Senior Medical Safety and Complaints Specialist

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:

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. You’ll play a pivotal part in identifying trends, safeguarding patients, and influencing improvements to products that directly affect millions of patients every year. 

What You’ll 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 required – we are looking for clinical depth of knowledge. 

• Experience: 5–10 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 communication—able 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 don’t wait to be told what needs doing—you just do it. 

• Collaborative Spirit: You enjoy working