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.

• Lead vendor processes.

• Support CE and FDA certification processes.

• 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.

• Establish and/or maintain Quality Systems.

• Prepare & submit global registrations worldwide: coordination and preparation of document packages for regulatory submissions.

• Lead Risk Management processes.

• Support design and development of products from a quality and / or regulatory perspective.

• Develop or support DMR, DHR, DHF

• Prepare annual strategy or planification’s for quality and regulatory activities (i.e. trainings, audits…)

• Advice on standards i.e. labeling UDI requirements.

• Lead or support special processes such as sterilization, cleaning, biocompatibility etc. –planning and managing the process to success.

• 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.

• Knowledge of the various stages of the product life cycle: design, clinical trials, manufacturing, and distribution phases

• Knowledge of Medical Device Quality and Regulatory requirements are essential (i.e.: CE, FDA, PAL, PMDA, TGA, CANADA etc.)

• Ability to deliver results. Effective communication, collaboration, and flexibility to learn new work environments and relationships with customers.

• Technical or scientific degree (BSc, MSc or PhD) 

• 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