Quality Assurance & Regulatory Affairs Specialist

At Cardiologs, our mission is to make tomorrow’s medical diagnosis efficient and accessible to everyone, anywhere, anytime. We leverage machine learning (AI) and cloud computing technologies to fulfill this vision. Our first product is a SaaS application to help physicians diagnose cardiac diseases, already deployed worldwide.

We are a tight-knit team and we nurture our company culture with monthly all-hands meetings and apéros, weekly yoga classes, climbing activities, daily coffee breaks in our comfy kitchen... But most importantly, we believe that a good atmosphere at work makes people more efficient on what they are best at!


What you’ll do


As part of the QARA Specialist activities, you will be working alongside our QARA Manager and you will:

  • Coordinate and participate in quality activities (QMS development and maintenance, audit, NC/CAPA, complaints, change control, PMS, on-boarding, and training etc..);
  • Ensure product compliance in coordination with the R&D team: ensure regulatory & quality requirements are met, lead product-related RAQA activities (risk analysis, technical file etc.) & perform product release;
  • Support Engineering team by maintaining and periodically executing the manual test plan of the platform. Create and assign discovered bugs to the engineering team
  • Implement the company’s regulatory strategy, managing international and domestic filings/registrations, including drafting and compiling of 510(k) Premarket Notifications, CE technical files, STED Documents, and related submissions;
  • Assist in developing, maintaining and implementing policies and processes that enable consistent, effective privacy practices of protected health information (PHI).


Who you are


  • An autonomous, committed, enthusiastic Bachelor’s graduated in Science or related field of study or related experience in the medical device industry
  • Ideally already worked between 2 and 5 years in medical device QARA field
  • You have knowledge of the normative and regulatory environment related to medical devices
  • You have knowledge of ISO 13485, ISO 14971 standards (IEC 62304 and IEC 62366-1 standards are a plus)
  • Capable of analysis and conviction
  • Able to work in an ambitious and rapidly growing startup context
  • Fluent in spoken and written English


Bonus:

=> You have previous experience and/or strong interest in developing healthcare products.

=> You already worked in a startup environment.


Our Recruiting Process


  • An introductory phone call
  • Technical interview
  • Performance interview
  • Culture interview with lunch (or drinks) with the team