Regulatory Affairs Officer - Medical Devices - Liège
Our Client is a is an innovative Medical Devices company based in Liège. The company has been developing for more than 30 years a range of innovative products, designed in partnership with ophthalmic surgeons and in close cooperation with specialized research centres and universities.
Their expertise covers all steps of development and manufacture of intraocular lenses extending from polymer chemistry to sterilization processes, responding to the strictest requirements in quality.
You are looking for a professional challenge that allows you to work in a start-up environment in order to participate to the registration activities?
You have acquired experience with international submissions in the medical devices industry and you want to participate to international Regulatory Affairs Projects ?
Plus One can offer you this great challenge:
Write, edit and review comprehensive regulatory and technical documentation, application dossiers and summaries of technical file.
Play an active role in the definition of the registration roadmap and timelines to achieve registration strategy globally
Support cross functional alignment initiatives to ensure compliance on Regulatory and Clinical activities
Provide technical and product expertise to regulatory and commercial agents for the countries he / she is responsible
Handle administratively and keep up-to-date registration files, change notification and tenders for the countries he / she is responsible
Maintain submission and technical documentation, licenses and records up-to-date
Maintain certification in the countries he / she is responsible
Ensure documents are produced in accordance with applicable internal and external procedures, guidelines, regulations and standards