Quality Assurance & Regulatory Affairs Specialist

About us

We build artificially intelligent solutions to hard clinical problems.

We are a health-technology company driven by the belief that expertise in cardiology should be scalable and accessible to everyone, anywhere, anytime.

We leverage machine learning (AI) and cloud computing technologies to fulfill this vision.

Our first product is a web-based platform specifically designed for healthcare professionals to simplify and improve the long and difficult task of interpreting ambulatory ECGs.


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


What you will do

  • Develop and maintain the Quality Management System to ensure compliance with applicable regulations and the company’s policy.
  • Ensure product compliance: guarantee that regulatory requirements are met in regards to local and international regulations and company standards
  • Maintain & update of technical files and necessary documentation for product release
  • Provide continuing regulatory and quality awareness and trainings
  • Participate in internal and regulatory audits
  • Drive product and QMS process risk activities
  • Perform regulatory and standard watch
  • Participate in post-market activities (PMS report, complaints, vigilance etc.)
  • Document and coordinate NC & CAPA process
  • Support the overall registration strategies: coordination, implementation, execution, control and completion of product registrations
  • Support Engineering team by maintaining and periodically executing the manual test plan of the platform. Create and assign discovered bugs to the engineering team 
  • Provide regulatory support to sales and marketing (promotion & communication) 
  • Assist in developing, maintaining and implementing policies and processes that enable consistent, effective privacy practices of protected health information (PHI)
  • Collaborate with the DPO to ensure alignment between security and privacy compliance programs including policies, practices and investigations


Job requirements

  • Bachelor’s Degree in Science or related field of study or related experience in the medical device industry
  • Ideally two (2) to five (5) years’ experience in medical device QARA field
  • Knowledge of the normative and regulatory environment related to medical devices
  • Knowledge of ISO 13485, ISO 14971, IEC 62304 and IEC 62366-1 standards
  • Capacity of analysis and conviction
  • Ability to work in an ambitious and rapidly growing start up context
  • Practice of English in a professional environment


Bonus points if you have

  • Previous experience and/or strong interest in developing healthcare products.
  • Previous experience in a startup environment


What we value

We value a positive mindset, collaboration, sense of ownership, transparency, the ability to embrace ambiguity, talk-less-do-more attitude and sense of humor to enjoy ourselves along the way.

If you identify with our values and want to contribute to our company, we’d love to have you in!


Benefits

  • Beautifully by-the-book startup offices in central Paris
  • A respectful, fun, collaborative work environment
  • Weekly yoga classes
  • Fresh fruits and healthy (or not) snacks
  • Monthly apéros
  • Yearly team off-sites
  • After-hours climbing buddies


The recruiting process

  • An introductory phone call
  • Technical interview (preferably on-site)
  • Performance interview (preferably on-site)
  • Culture interview with optional lunch with the team (preferably on-site)