Companies you'll love to work for

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  • \nRAQA Specialist\n
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    • \n\nParis\n
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    • \n\nFull-Time\n
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  • \nApply Now\n\n
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\n\"OWKIN\"\n\n
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\nOWKIN\nIs Hiring!\n

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\nRAQA Specialist\n

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\nAbout\n

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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.

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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).

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

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\nJob Description\n

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About us

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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.

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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).

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

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About the role:

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

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Support the implementation of Owkin's global quality and regulatory strategies for its In Vitro medical device software

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  • Regulatory Affairs

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    • Support and apply regulatory strategies in line with the targeted countries and priorities (at least for the European Union)

    • \n
    • Support implementation and maintenance of regulatory related documents (Technical documentation, documents to be submitted to regulatory authorities, change requests etc.)

    • \n
    • Support 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

    • \n
    • Support identification and monitoring process, evaluation of impact, and implementation of new regulations, standards and guidelines

    • \n
    • Be one of the contacts for communication with authorities (request, submission, vigilance)

    • \n
    • Participate to the regulatory review of promotional materials

    • \n
    \n
  • Quality Assurance

  • \n
      \n
    • 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.

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

    • \n
    • Support the qualification of tools and suppliers

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

    • \n
    • Support internal and external audits

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Position is based in our Paris offices or remotely.

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About you

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Required qualifications / experience:

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  • Engineering, MSc or equivalent degree in quality / regulatory affairs

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  • A good level of successful experience within regulatory affairs and in quality management systems relating to medical devices/in vitro diagnostic medical software devices

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  • 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...)

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  • Knowledge on machine learning is a plus

  • \n
  • You are able to work independently and as part of a team

  • \n
  • You have organizational and planning skills, including being action oriented, focus urgency and driving for results

  • \n
  • You have great capacity for relational adaptation which will allow you to integrate quickly into a young dynamic team

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  • Experience in digital pathology is strongly preferred

  • \n
  • Fluent in English, French is a plus

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What we offer

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

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  • Please attach a CV.
  • \n
  • 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.
  • \n
  • 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:
  • \n
  • Legitimate Owkin recruitment processes include communication with candidates through recognized professional networks, such as LinkedIn. However, further
  • \n
  • 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);
  • \n
  • 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;
  • \n
  • \nLegitimate 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\n
  • \n
  • 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.
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If you think that you have been a victim of fraud,

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\nAdditional Information\n

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  • \nContract Type:\nFull-Time\n
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  • \nLocation:\n\nParis\n\n
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  • \nPossible full remote\n
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\nSounds like something made for you?\n

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","datePosted":"2023-09-13T13:07:40.340Z","employmentType":[],"hiringOrganization":{"@type":"Organization","name":"Owkin","sameAs":"https://owkin.com","logo":"https://cdn.getro.com/companies/58797d0f-58a6-5572-beab-f2fb0c2e179d"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Paris, France"}}}

RAQA Specialist

Owkin

Owkin

Operations
Paris, France
Posted on Wednesday, September 13, 2023

OWKIN Is Hiring!

RAQA Specialist

About

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.

Job Description

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, 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 and apply regulatory strategies in line with the targeted countries and priorities (at least for the European Union)

    • Support implementation and maintenance of regulatory related 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 and post market activities, including participation to the risk analysis of the product

    • 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)

    • Participate to the 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…) 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

    • Support the qualification of tools and suppliers

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

    • Support internal and external audits

Position is based in our Paris offices or remotely.

About you

Required qualifications / experience:

  • Engineering, MSc or equivalent degree in quality / regulatory affairs

  • A good level 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 15223-1 / ISO 18113-1, ISO 14971, IEC 62304 / IEC 82304-1, IEC 81001-5-1, IEC 62366-1, EN 13612...)

  • Knowledge on machine learning 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, 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,

Additional Information

  • Contract Type: Full-Time
  • Location: Paris
  • Possible full remote

Sounds like something made for you?