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Technical Responsible – (21I/TRRA)
Randox Laboratories are currently seeking a highly motivated individual to act as the Technical Responsible person on behalf of our company in Brazil.
• Assist with all requirements of registering the Randox product line directly in Brazil and other Latin American countries as required by the Regulatory Affairs Department.
• Act as the Technical Responsible person on behalf of the company in Brazil to Anvisa.
• Prepare regulatory documentation, review, and interpret previous regulatory documents, technical information, and performance data to ensure compliance with national/international regulations and standards.
• Compile, submit and follow up on registration files to obtain and maintain marketing authorisations for IVD Medical Devices and to manage them throughout the life cycle and respond to questions from various regulatory authorities.
• The creation of and updating of Product Technical files for compliance with the IVD Directives in the relevant countries.
• Review and approval of product labelling (Labels and IFU) for Randox off the shelf product.
• Translation of IFU’s, labels, dossier and SDS’s to ensure compliance with regulations.
• Complete supplier survey forms.
• Conduct internal audits.
• Development and revision of manuals. Procedures and technical instructions.
• Report recalls or customer notifications to Anvisa.
• A bachelor’s degree or equivalent in Pharmacy.
• Previous experience as a Technical Responsible Person.
• Previous experience in preparing product dossiers for Class I, II and III products.
• Previous experience in submitting information to Anvisa.
• Excellent verbal and written communication.
• Ability to act on own initiative or as part of a team.
• Fully computer literate.
• Organisational skills.
• Fluent in English.
• Knowledge of registrations in other countries.
• Knowledge and experience of Quality Systems.
• Knowledge of 16/2013 resolution.
• Auditing experience.
• Knowledge of completing and reporting recalls.
Randox is a world leader in in-vitro diagnostics supplying a range of innovative laboratory instruments and tests to a wide range of customers across the globe. Our mission is to create added value in healthcare by focussing on our expertise in diagnostics.
We play a pioneering role in laboratory medicine. High value is placed in research and development to continuously improve existing and develop innovative new products. This has allowed us to continuously grow and expand our international sales teams. Now is your chance to be part of strong, growing organisation.