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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.

  • 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

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