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Quality assurance /regulatory affairs associate

Bruxelles
Walter Welton
Publiée le 12 mai
Description de l'offre

This is your chance to work with innovative products and be part of something that will have a real impact in the Medical Devices industry. You will be working closely with the engineers to develop products. That will also be an opportunity to follow the whole process from A to Z and have your word! The QA/RA Associate shall provide support for the development of innovative medical devices, as part of the QA/RA team. (S)he will provide support in Quality Assurance and Regulatory Affairs activities such as, but not limited to: Quality Management System implementation Standards watch and gap analysis Audits Compilation of documentation for notified bodies, FDA, competent authorities Your responsibilities Good understanding of medical devices regulatory environment (MDD 93/42, MDR) Good knowledge of medical devices quality assurance (ISO 13485) and relevant standards Work cross-functionally in identify and resolve various quality issues, participate in CAPA management Promote a quality culture throughout the company English and French/Dutch You are Passionate about life sciences, technology and innovation Quality and customer-service oriented Focused on details Strong communication and organizational skills Autonomous & quick learner Flexible & open-minded Your qualifications Min. 2 years of relevant experience in medical devices QA/RA functions Knowledge of QMS Fluent in English and French Offer & benefits The opportunity to contribute to the development of products that will improve or save people's life A valorizing job within an ambitious and growing company in a booming industry A great team of enthusiastic people led by passionate experts in MedTech A nice working environment in Brussels, very close to the forest of Soignes, a park, nice shops and restaurants, public transport connections And of course, a good salary package and extra benefits!

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