Senior Medical Safety and Complaints Specialist

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 across functions and value diverse perspectives when solving problems. 

You’ll 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.