Qa/Ra Technician

Operating Company: Nobel Biocare Location: Barcelona, Cataluña, ES Date Posted: August 6, 2024 Req Number: R5019853 Job Description: This role is to cover a vacancy at Mimetis Biomaterials (https://www.linkedin.com/company/mimetis/), a small medical device company located in Barcelona which is part of Nobel Biocare.
The Quality Assurance and Regulatory Affairs Technician is accountable for timely execution of quality activities and regulatory strategies to support launch activities and maintain compliance status for Mimetis Biomaterials products.
Job Requirements: Support for the set-up, maintenance and documentation of QMS (writing and updating SOP and WI) Ensure the effective implementation of internal procedures and processes.
Ensure the management of appropriate QA processes (CAPA, Non-conformities, FSCA, Complaints, Document and Change control, etc.)
Define and implement appropriate Quality actions and trainings Support internal and external audits in the audit preparation and audit back office.
Support Medical Device registration/notification – class III products and technical documentation submission Support execution of regulatory strategies for access to main markets EU, US and update product strategy based on regulatory changes.
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