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.
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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.
Operating Company:
Nobel Biocare
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What We Do
Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its partners deliver the best possible patient care through industry-leading products, solutions, and technology. Our comprehensive portfolio covers a wide range of dentists' clinical needs for diagnosing, treating, and preventing dental conditions, as well as improving the aesthetics of the human smile.
Our differentiated combination of continuous improvement, a bias toward action and innovation, and a deep respect for the more than one million professionals we serve embolden us to champion dental professionals like no one else can.
The operating companies that form Envista, including Nobel Biocare, Implant Direct, Ormco, DEXIS, Kerr, Metrex, and more represent more than 125 years of dental industry excellence. These brands meet the end-to-end needs of dental professionals worldwide.
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