Complaint Specialist (Remote)

HeartFlow, Inc. is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the HeartFlow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. HeartFlow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.

HeartFlow is a VC-backed company that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 350,000 patients worldwide.

The Complaint Specialist will play a critical role in the timely review of complaints to ensure investigations are complete and well documented, and regulatory reporting determination documentation.

This position requires an understanding of Medical Device regulatory obligations for compliance within the scope of the department (E.g., US FDA 21 CFR 820.198, 21 CFR 803, 21 CFR 806, EU MDR, UK Regulations, Health Canada MPR, JPN PMDA Regulations and other global post-market regulatory obligations as required).

Primary responsibilities include, but are not limited to identifying, reviewing and processing complaints for evaluation as required by applicable regulations, standards, and company policy. Assist Customer Support and serve as a liaison for complaint escalations. Review of complaint investigations and trends. General understanding of CAPA, NCR, and Health Hazard Evaluation and Risk Management.

Job Responsibilities:

• Assess reports received through multiple customer feedback channels to identify alleged deficiencies
• Ensure accurate documentation, evaluation, reporting determination and investigation results
• Post-market surveillance and vigilance reporting
• Manage timely and compliant complaint records review and closure
• Own the complaint tools and processes with a vision towards process improvement and streamlining
• Provide post-market metrics and data as needed
• Support Quality Management System, as needed
• Ability to work in a fast-paced adaptive environment, self-starter, and strong team player required.
• Assist Customer Support and serve as a liaison for complaint escalations
• Review of complaint investigations and trends. General understanding of CAPA, NCR, Health Hazard Evaluation and Risk Management.
  
  

Skills Needed:

• Knowledge of US and International regulatory post-market requirements
• Critical thinking skills and great attention to detail
• Experience with software medical device product preferred
• Experience with EDMS - Electronic Document Management System
• Excellent communication, documentation and time management skills
• Proficient with Salesforce platform preferred
• Proficient with Windows, MS Office, Excel and PowerPoint skills
  
  

Educational Requirements & Work Experience:

• Bachelor’s degree preferred
• 2-5 years’ relevant experience in medical device industry or related experience
  
  

This position has an estimated base salary of $65,000-$85,000, cash bonus, and stock options.

HeartFlow, Inc. is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at HeartFlow, including recruitment, hiring, training, relocation, promotion, and termination.

Positions posted for HeartFlow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.