Senior RAQA Engineer

Owkin

Owkin

Nantes, France · Remote · Paris, France · France
Posted on Monday, January 15, 2024

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 the role:

As a member of the Quality and Regulatory Affairs team in the Diagnostics department and reporting to the RAQA director, you will be supporting the implementation of Owkin's global quality and regulatory strategies for its In Vitro medical device software and other software products.

In particular, you will:

  • Regulatory Affairs

    • Support the definition and execution of regulatory strategies in line with the targeted countries and priorities (at least for the European Union) and aligned with the company's objectives.

    • Coordinate and support the implementation and maintenance of regulatory related documents (Technical documentation, documents to be submitted to regulatory authorities, change requests etc.)

    • Support the development team to ensure all regulatory requirements are met throughout the development process and post market activities, including participation to the risk analysis of the product

    • Ensure the 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)

    • Participate to the regulatory review of promotional materials process improvement and implementation

  • 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…) including the management of non-conformities, CAPA or complaints analysis.

    • Contribute to the development of procedures, work instructions and other documents related to the QMS

    • Contribute to product releases

    • Support the qualification of tools and suppliers process

    • Collaborate with the entire team to maintain good practices and compliance.

    • Pilot internal and external audits activities

Position is based in our Paris or Nantes offices or remotely in France.

About you

Required qualifications / experience:

  • Engineering, MSc or equivalent degree in quality / regulatory affairs
  • 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 15223-1 / ISO 18113-1, ISO 14971, IEC 62304 / IEC 82304-1, IEC 81001-5-1, IEC 62366-1, EN 13612... MDSAP is a plus
  • You are able to work independently and as part of a team
  • You have organizational and planning skills, including being action oriented and problem solving
  • You have great capacity for relational adaptation which will allow you to integrate quickly into a young dynamic team
  • Excellent written and verbal communication in English, French is a plus

Preferred qualifications/bonus:

  • Knowledge on machine learning is a plus
  • Ideally you have experience in digital pathology

#LI-MD1

What we offer

  • 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 complete the form and submit your 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.
  • Communication is always through an official Owkin email address (from the @owkin.com domain), over the phone or though our applicant tracking system (Greenhouse).
  • The Owkin talent team do use platforms such as LinkedIn and Job Teaser, however if you have any concern or doubt about this contact, please ask for them to send an email from @Owkin.com.
  • The Owkin talent team 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 (Google Meets). They will not occur via Signal, Telegram or Messenger
  • Owkin offers of employment are based on merit and only extended once a candidate has interviewed with members of the talent and hiring team. Offers will be extended both verbally and in written format.

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