In order to support our growth, we are strengthening our Quality and Regulatory Affairs division.
Under the direction of the Quality and Regulatory Affairs manager, you will be in charge of the daily contact with the Delmont imaging teams. This internship can lead to permanent contract if the internship is successful.

Your missions & projects :

• Verify the proper implementation of the quality system in the company
• Participate in its evolution with the various departments concerned
• Ensure the conformity of finished products and manage non-compliances
• Participate in the updating of technical files
• Participate in the preparation of documents for international medical device registration
• Participate in internal audits and the ISO 13485 follow-up audit

• Diploma: Master level (biomedical engineer or quality master)
• Specialization: medical devices, quality, regulatory affairs
• English: Level B2
• Mastery of ISO 13485, Directive 93/42/EC, ISO 14971, MDR,
• Mastery of the different aspects of the design of a medical device and design documents
• Good knowledge of the content of a technical file (applicable standards, essential requirements, RGR, clinical evaluation, user manual, medical device classification, post-market surveillance, etc…)
• Organized and structured
• Excellent sense of communication