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Senior RAQA Engineer

fully flexible

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

France

Offer summary

Qualifications:

Engineering, MSc or equivalent in quality/regulatory affairs., At least 5 years of experience in regulatory affairs and quality management systems., Proficient in medical device regulations and standards., Experience in clinical trials is a plus..

Key responsabilities:

Support implementation of regulatory strategies.
Maintain regulatory documents and communicate with authorities.

Owkin Startup https://www.owkin.com

201 - 500 Employees

See all jobs

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 and reporting to the Head of RAQA, you will be supporting the implementation of Owkin's global quality and regulatory strategies for its In Vitro medical device software and other AI systems.

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 the USA) 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 leading 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, QMSR, AI act…) 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
Ensure product releases and change approval
Pilot internal and external audits activities
Support the qualification of tools and suppliers
Collaborate with the entire team to maintain good practices and compliance.

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

About you

Engineering, MSc or equivalent degree in quality / regulatory affairs
At least 5 years of successful experience within regulatory affairs and in quality management systems relating to medical devices/in vitro diagnostic medical software devices and/or clinical studies/trials
You master the regulations for medical devices (MDR and FDA 510(k)/De novo/PMA minimum, IVDD/IVDR is a plus), ISO 13485 QMS, medical devices standards (ISO 14971, ISO 15223-1, IEC 62366-1,...) and medical device software standards (IEC 62304 / IEC 82304-1, IEC 81001-5-1,...)
You have experience on clinical trials / clinical studies standards and regulations (GxP requirements, GCP/GLP, ICH E6 R3, FDA IDE, ISO 20916 or ISO 14155) - Experience in CDx regulations is a plus
You are able to work independently and as part of a team, in a fast-paced environment
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
Experience in digital pathology is strongly preferred
Fluent in English, French is a plus

Please submit your CV in English

#LI-MD1

What we offer

Flexible work organization
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.