Internship in Regulatory Affairs and Quality
il y a 2 semaines
Based in Antony, France, SPINEVISION, a Medical Device company which provides innovative solutions for the treatment of various spinal pathologies, is looking for an Intern for the Regulatory Affairs & Quality Assurance department.
Provide support in maintaining the quality assurance system in compliance with the company’s quality policy and current regulations, in order to market effective and reliable medical devices for the safety of patients and users.
Provide support to the regulatory affairs department for the registration of medical devices in the different countries where the products are marketed.
- Support in the constitution of technical files for the CE marking of products and keep the files up to date according to the regulations in force
- Support in the creation of technical files outside Europe (Canada, Brazil, Australia, etc.)
- Operational follow-up of the company’s design change and change control
- Ensure the global follow-up of the quality indicators of the company’s processes
- Follow the implementation of the data register in the framework of the RGPD
- Participate in the normative and regulatory watch
- All other missions that will be requested by the hierarchy
- Bonus: Evaluate the feasibility of implementing a quality monitoring software
Master’s degree or equivalent in the medical, biomedical or pharmaceutical sector - focused on quality and regulatory affairs
Biomedical Engineering School, ISIFC, UTC
Main skills:
- Know the directives and regulations associated with medical devices
- Know the documents and the quality process
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