Quality and Regulatory associate Junior

hace 2 semanas

barcelona, España Mediktor A tiempo completo

Mediktor is looking for a QA/RA specialist If you are passionate about applying the regulation to cutting edge technology and you would like to discover the Software Medical Device regulation, we are looking for you The Team: As a member of the Quality Department, you will collaborate closely with all teams and departments at Mediktor, supporting them in meeting regulatory and quality requirements. You will play a key role in the implementation and maintenance of an integrated management system, ensuring effective compliance with the AI Act, MDR, and accessibility standards across the organization. Responsibilities: Manage and update Integrated Management System documentation to ensure organization-wide compliance. Participate in internal and external audits to verify adherence to quality standards. Partner with teams to integrate and uphold quality requirements across departments. Validation & Risk: Execute and oversee the validation systems and the risk management framework to mitigate operational gaps. Direct the CAPA and Change Order processes to drive continuous improvement. Execute supplier evaluations to ensure high-quality procurement standards. Strategic Support: Perform additional duties and key projects as assigned. Requirements: Life Science Degree studies Fluent in English and Spanish Strong attention to detail Excellent communication and interpersonal skills, and a desire to learn and grow professionally At least 1 year of experience in a QA/RA role (including trainee position) We Are Looking For Someone With a curious mind to be up to date of what is going on in the company and the trends and innovations of the sector. What you will find working with Mediktor: An exciting scale-up company sharing good vibes & excellent multicultural and team working environment

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