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Apprentice Quality Assurance and Regulatory Affairs Specialist

Il y a 2 mois


Lille, Hauts-de-France Celeos SAS Temps plein
Quality Assurance and Regulatory Affairs Engineer Apprentice

Celeos SAS is an innovative medical device manufacturer acting predominantly in the oncology segment for human surgical applications. We are committed to improving human and animal health and their well-being while minimizing our environmental footprint.

About the Role

We are seeking a Quality Assurance and Regulatory Affairs Engineer Apprentice with knowledge of the medical device field to join our team. The successful candidate will assist in developing our regulatory roadmap and coordinating medical device validation projects.

Key Responsibilities
  • 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. Realize data aggregation and participate in regulatory file preparation.
  • Support the development and maintenance of an electronic Quality Management System (QMS).
Requirements
  • Ongoing Master's degree in a relevant field such as Life Sciences, Pharma, Biomedical Engineering, or Regulatory Affairs.
  • Understanding and knowledge of quality concepts and professional practices, quality assurance, solid basics in statistical analysis with univariate and multivariate methods, notions in Public health and health law, and Medical Devices.
  • Proficiency in English. French is a plus.
Our Culture

Celeos SAS is a purpose-driven company with a strong commitment to our values. We believe in fostering a healthy and fulfilling work environment that nurtures creativity and productivity while promoting flexibility.

This full-time position is a hybrid role with a mix of on-site and remote work. It offers an opportunity for a future long-term contract with 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.