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We are always eager to meet motivated people who share our vision and wish to be part of our team.

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

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:

  • 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: 

  • 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.

Desired experience and skills:

  • 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.

For additional information on posting above and to send your CV please mail to hr@hamada.co.il

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