Quality Assurance and Regulatory Affairs Engineer
il y a 3 semaines
Celeos SAS is a dynamic and innovative medical device manufacturer operating primarily 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.
Job DescriptionWe are seeking a Quality Assurance and Regulatory Affairs Engineer to join our team. As a key member of our regulatory team, you will be responsible for developing and maintaining our regulatory roadmap, coordinating medical device validation projects, and ensuring compliance with relevant regulations and standards.
Key Responsibilities:- 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
- Realize 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
- Ongoing Master's degree in relevant field such Life Sciences, Pharma, Biomedical Engineering or Regulatory Affairs
- 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
- 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
Celeos SAS offers a dynamic and fulfilling work environment that nurtures both creativity and productivity while fostering flexibility. We are committed to improving human and animal health and their well-being while minimizing our environmental footprint.
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