Apprentice in Quality Assurance and Regulatory Affairs

Job description

Description

An Inside Look at CELEOS

CELEOS is an innovative medical device manufacturer acting predominantly in oncology segment for human surgical applications. We are looking for a Quality Assurance and Regulatory Affair Engineer Apprentice with knowledge of the medical device field to take part of the growing company.

CELEOS is a DeepTech and HealthTech company created as a result of more than 10 years of academic, pre-clinical, and clinical research at the University of Lille. We developed an innovative, patented technology solution to acquire specific molecular signatures from tissue samples without damage. Verified through scientific studies on various cancer types and validated via a clinical trial in dermo-cosmetics, the technology can provide a real-time assistance to surgeons. It aims to minimize incomplete tumour removals, resulting in improved patient outcomes and enhanced quality of life.

CELEOS is a purpose-driven company committed to improving human and animal health and their well-being while minimising our environmental footprint. Our core values embodied by the “4Cs”: Consistency, Consideration, Consultation & Courage – guide our commitment to excellence.

In the upcoming years, Celeos plans to introduce its product to renowned cancer treatment centres in Europe and the United States to become a new standard surgical guidance tool. To achieve this, we are looking for a Quality Assurance and Regulatory Affair Engineer apprentice to join our team.

How You'll have an Impact:

Reporting to the Chief Technology Officer, you will assist in developing Celeos regulatory roadmap and coordinating our medical device validation projects. Your role will be to:

· Support the development and maintenance of an electronic Quality Management System (QMS).

· Contribute to the management and optimization of Laboratory Information Management Systems (LIMS) and electronic lab notebooks (e-labbook).

· Participate in the preparation for CE marking of a SpiderMass medical device and ISO 14845 certification. Participate in discussions with the Notified Body.

· Realize the data aggregation and participate in regulatory file preparation.

· Assist in the preparation and submission of regulatory documents to FDA/ ANSM/ MHRA

· Help in the preparation of non-clinical and clinical trials.

· Framework the benefits granted to healthcare professionals (relation CNOM)

· Monitor regulatory guidelines and standards relevant to our technologies and market.

What Expertise We're Looking For:

We are looking for a candidate with ongoing Master’s degree in relevant field such Life Sciences, Pharma, Biomedical Engineering or Regulatory Affairs and understanding and knowledge of:

· quality concepts and professional practices, and quality assurance,

· basics of clinical evaluation,

· solid basics in statistical analysis with univariate and multivariate methods,

· regulatory environment for health products,

· notions in Public health and health law,

· Medical Devices: general principles in design and distribution of medical devices,

· project management experience,

· proficiency in English. French is a plus.

A prior contact with highly regulated fields (i.e. medical device development or pharmaceuticals) would be appreciated.

The Soft Skills That Make a Difference:

At Celeos, soft skills play a significant role alongside the technical expertise. Our 4Cs shape our culture, and having an organized, systematic approach, along with these other attributes, will ensure your success in our team.:

· Reliability & Resilience : Consistently meeting high standards and dealing with failures.

· Respect & Teamwork: Recognizing and valuing the contributions of all individuals, offering constructive feedback, and interacting with others in a considerate and respectful manner.

· Analytical & Innovative mindset: Thinking creatively, making informed decisions, and fostering collaboration among team members.

· Integrity & Courage: Demonstrating integrity by advocating for ethical behaviour and acting honestly, even in challenging circumstances. These values establish trust and uphold our reputation as an organization guided by strong principles.

Why You'll Love Working Here

On top of being mission-oriented, working at Celeos means being part of a dynamic and dedicated team in Lille, a city renowned for its delicious cuisine and its proximity to three major European capitals.

This full-time position is a hybrid role with a mix of on-site and remote work. It is an opportunity for a future long-term contract with a professional growth in a healthy and fulfilling work environment that nurtures both creativity and productivity while fostering flexibility.

The application process involves submitting a CV and cover letter or a video resume. Interested candidates should be prepared to participate in a series of interviews, technical and soft skills assessments.

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