We are always eager to meet motivated people who share our vision and wish to be part of our team.
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To meet our clients’ expectations through the development, implementation, and delivery of their products we are currently looking to add to our team, the following:
QARA Professionals
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We offer to QARA leaders in the Medical Device industry a high profile and exciting job, learning how to operate as a consultant and widening and deepening their professional capabilities.
Job Description:
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Establish, improve, and maintain QMS Systems, from design to manufacturing and distribution stages of the company.
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Lead vendor processes.
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Support CE and FDA certification processes.
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Prepare documents and design dossiers in support of CE marking (MDR or IVDR), FDA submissions, ROW, Create regulatory strategies.
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Among your duties you may be requested to:
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Create Technical File/Documentation for all device classes and various geographies.
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Establish and/or maintain Quality Systems.
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Prepare & submit global registrations worldwide: coordination and preparation of document packages for regulatory submissions.
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Lead Risk Management processes.
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Support design and development of products from a quality and / or regulatory perspective.
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Develop or support DMR, DHR, DHF
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Prepare annual strategy or planification’s for quality and regulatory activities (i.e. trainings, audits…)
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Advice on standards i.e. labeling UDI requirements.
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Lead or support special processes such as sterilization, cleaning, biocompatibility etc. –planning and managing the process to success.
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Participates, or lead internal and external audits i.e. FDA inspections, notified body audits according to ISO13485, EU MDR, MDSAP.
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Desired experience and skills:
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Minimal 5 years working experience in various areas of Medical Devices: Radiation Emitting Systems, AI, SaMd, Imaging, Implants, cardiac applications, cannabis etc.
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Knowledge of the various stages of the product life cycle: design, clinical trials, manufacturing, and distribution phases
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Knowledge of Medical Device Quality and Regulatory requirements are essential (i.e.: CE, FDA, PAL, PMDA, TGA, CANADA etc.)
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Ability to deliver results. Effective communication, collaboration, and flexibility to learn new work environments and relationships with customers.
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Technical or scientific degree (BSc, MSc or PhD)
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Fluent in English.
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For additional information on posting above and to send your CV please mail to hr@hamada.co.il