QARA manager

24.06.2021

ImVitro is looking for a mission-driven QARA manager to join the Paris-based company as one of the first team members to tackle a problem that concerns around 15% of couples worldwide: infertility. The ideal candidate is someone with 1-2 yrs of experience as a QARA manager applied to software medical devices.

Today, one of the main medical solutions to infertility is in vitro fertilization (IVF). And yet, its success rates only come close to 20-30% in Europe, which means patients have to repeat this difficult journey all too often, or give it up altogether. At ImVitro, we minimize the number of cycles patients have to go through by personalizing medical decisions to each patient’s journey. We apply AI to a variety of data that is routinely used by doctors to make complex and multifactorial decisions, starting with videos of developing embryos. We predict the impact of these customized decisions on success rates, thus making IVF more transparent, robust and reproducible. Our vision is to create an easier path to parenthood to ensure families can take their planning into their own hands.

ImVitro is an early stage Deep Tech start-up backed by US & European VC funds. It was founded in August 2019 and has already created strong partnerships with fertility centers. The company has been backed by several accelerator programs  (Entrepreneur First, DeepTech4Good, Wilco, Agoranov) and was selected as one of Station F’s Future 40 2019 start-ups. 

Role and responsibilities

Candidates must be results & action oriented, with an ownership mindset and ability to be flexible with change. This is a unique opportunity to be a core team member of a fast-paced, demanding and exciting entrepreneurial ecosystem. 

This person will be managed by the operations manager, but will also interact heavily with the CEO and the future technical director to help define the regulatory roadmap and get the ISO 13485 certification. They will also heavily interact with the tech team to ensure day-to-day full compliance of the software development with standards and regulations. This person will also interact with our consultants on a somewhat regular basis who will act as back-ups for complex regulatory matters.

As a QARA, you will be responsible for:

  • Managing files submissions and audits with external bodies
  • Coordinating the writing of the technical documentation by team members in accordance with the product roadmap
  • Maintaining and continuously improve ImVitro’s quality management system

Skills

Above all, the candidate needs to be excited about the mission of the company, and needs to be driven, curious and autonomous.

Must-haves:

  • Fluent in English (written and spoken)
  • Up to 3 years as QARA in software medical devices & at least a first experience in software medical device (internship)
  • Knowledge of ISO 13485 and IEC 62304 standards
  • Knowledge of the main standards related to medical devices (Directive 93/42 / EEC, Regulation 2017/745)
  • Knowledge of transversal standards related to ISO 14971 medical devices

Nice-to-haves:

  •      Exposure to FDA regulations

Compensation & Perks

The employee will 

  • Receive a competitive salary and ESOP
  • Have access to central offices in Paris at Agoranov, a prestigious Deep Tech incubator and be part of its amazing network of entrepreneurs and scientists
  • Participate in regular company events (e.g. team lunches, drinks)
  • Flexible work arrangements
  • Have the opportunity to make an impact on patients and society at large

Recruitment process

  • Send CV or LinkedIn profile link to alexandra@im-vitro.com
  • 30 min introductory video call with the founder
  • Second in-depth 45 min interview for skills and challenge assessment with operations manager & CEO
  • Conversation with extended team