Regulatory Affairs & Quality Assurance Engineer

Regulatory Affairs & Quality Assurance Engineer

About us

Owkin is an AI biotechnology company that uses AI to find the right treatment for every patient. We combine the best of human and artificial intelligence to answer the research questions shared by biopharma and academic researchers. By closing the translational gap between complex biology and new treatments, we bring new diagnostics and drugs to patients sooner.

Owkin has raised over $300 million and became a unicorn through investments from leading biopharma companies (Sanofi and BMS) and venture funds (Fidelity, GV and BPI, among others).

Owkin is seeking the best and brightest to join our fast-growing and dynamic team.

About Diagnostics at Owkin

Our ambition is to potentiate precision diagnosis in oncology with artificial intelligence applied to digital pathology. Pathology slide images, taken from biopsied or resected tissues, are a yet-untapped, ultra-high dimensional data modality that offer a huge potential for deep learning application to better understand disease, optimize patient care & improve treatment decisions.

We have for instance developed two products based on AI and digital pathology to tackle major challenges in precision oncology:

The first one is about evaluating the risk of relapse in early breast cancer for a better adaptation of the therapeutic strategy.
The second one is about decreasing the burden of MSI screening for patients with Colorectal cancer. If detected, the MSI phenotype leads to a very specific care pathway with a treatment based on immunotherapy improving the chance of survival for the patient.

We are now looking for a Regulatory Affairs & Quality Assurance Engineer to join our Diagnostics department.

Main Missions

As a member of the Quality and Regulatory Affairs team, your missions are the following: 

  • Support the implementation of Owkin's global quality and regulatory strategies for its In Vitro medical device software
  • Regulatory Affairs
    • Support drafting and maintenance of regulatory documents (Technical documentation, documents to be submitted to regulatory authorities, change requests etc.) 
    • Support development team to ensure all regulatory requirements are met throughout the development process
    • Contribute to post market activities 
    • Define and apply regulatory strategies in line with the targeted countries and priorities
    • Support identification and monitoring process, evaluation of impact, and implementation of new regulations, standards and guidelines
    • Be one of the contacts for communication with authorities (request, submission, vigilance)
    • Regulatory review of promotional materials
  • Quality Assurance
    • Participate in the implementation and maintenance of the quality management system in accordance with the applicable regulations (ISO 13485, IVDR, FDA 21 CFR…)
    • Contribute to the development of procedures, work instructions and other documents related to the QMS
    • Collaborate with the entire team to maintain good practices and compliance.

You will work in collaboration with all the departments involved in the development and commercialisation of OWKIN’s medical products.

You will join a fast-growing, well-funded company with real potential to make an impact on the lives of patients.

About you

Required qualifications / experience:

  • Engineering, MSc or equivalent degree in quality / regulatory affairs
  • 3 years of successful experience within regulatory affairs and in quality management systems relating to medical devices/in vitro diagnostic medical software devices
  • You master the regulations for medical devices (MDR minimum, IVDD/IVDR is a plus, FDA 510k/De novo is a plus), ISO 13485 QMS, specificities for medical device software and associated standards (ISO 14971, IEC 62304, IEC 62366...)
  • Knowledge on machine learning is a plus 
  • You are able to work independently and as part of a team
  • You have organisational and planning skills, including being action oriented, focus urgency and driving for results
  • You have great capacity for relational adaptation which will allow you to integrate quickly into a young dynamic team
  • Experience in digital pathology is strongly preferred 
  • Fluent in English, French is a plus

What we offer

  • Competitive salary & excellent benefits package
  • Flexible work organization and access to remote work
  • Friendly and informal working environment
  • Opportunity to work with an international team with high technical and scientific backgrounds

Recruitment Process & Security

  • Please attach a CV.
  • Owkin is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, gender, sexual orientation, age, color, religion, national origin, protected veteran status or on the basis of disability.
  • Owkin is a great place to work. Unfortunately, being a coveted workplace means we are vulnerable to recruitment phishing scams. We urge all job seekers and candidates to be wary of potential scams. Most of these have individuals posing as representatives of prominent companies, including Owkin, with the aim of obtaining personal, sensitive, or financial information from applicants. These scams prey upon an individual’s desire to obtain a job and can sometimes “feel” like a genuine recruitment process. Some red flags are identified below. Should you encounter a recruitment process that claims to be for Owkin but is not consistent with the below, please do not provide any personal or financial information:
  • Legitimate Owkin recruitment processes include communication with candidates through recognized professional networks, such as LinkedIn. However, further 
  • communication is always through an official Owkin email address (from the @owkin.com domain), over the phone or though Recruitment platforms (WelcomeKit, talent.io, hidden.market, Fifty Talent or Hiresweet);
  • Legitimate Owkin recruiters will not solicit personal data from candidates during the application phase including, but not limited to, date of birth, social security numbers, or bank account information;
  • Legitimate Owkin interviews may be conducted over the phone, in person, or via an approved enterprise videoconferencing service (such as Google Meets or Highfive). They will never occur via Signal, Telegram or Messenger
  • Legitimate Owkin offers of employment are based on merit and only extended once a candidate has interviewed with members of the hiring team. Offers will be extended both verbally and in written format. Owkin may request some personal information to initiate the hiring process, but this will be through protected means.

 

If you think that you have been a victim of fraud, 

Role

Regulatory Affairs & Quality Assurance Engineer

Team

Location

Paris

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