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Here are our current job openings

We look forward to hearing from you.

Device RA Manager

Department
Regulatory Affairs
Location
Rehovot, Israel

We are looking for an experienced Device RA Manager.

Job description

  • Lead & Support regulatory and quality aspects of device and drug/device combination, through the product life cycle .
  • Build Regulatory strategy for development and submission along the project.
  • Review device related protocols/reports to ensure compliance with the regulations.
  • Lead all product compliance activities: Applicable standards, directives and guidance.
  • Point of contact for the authorities.

Qualifications

  • Bachelor’s degree or higher in mechanical engineering discipline.
  • At least 5 years of RA experience, in supporting a medical device development.

Pre-clinical RA Director

Department
Regulatory Affairs
Location
Rehovot, Israel

We are looking for a Pre-clinical RA Director to support product development.

Job description

  • Support pre-clinical aspects of product development with a focus on authoring/review of any internal and external documents (such as CSRs, CTA/IND/briefing books).
  • Routine review of relevant guidelines, protocols & reports, regulatory data of reference products, publications, etc.
  • Ensure compliance with guidelines and feedback from agencies.
  • Serve as RA representative in R&D product development project teams.
  • Review strategic documents pivotal to interaction with authorities.
  • Prepare and attend consultation meetings with regulatory agencies, as needed.
  • Contribute to authoring/review of regulatory submissions to FDA, regulatory authorities in EU and other territories, as needed.
  • Track, interpret and advise on US and European regulations, guidelines, procedures and policies within the scope of the company.

Qualifications

  • Minimum 5 years of experience in similar positions.
  • Comprehensive knowledge of the pharmaceutical - Required. 

System Engineer

Department
Device
Location
Rehovot, Israel

We are looking for an experienced System Engineer for developing new medical device in the drug delivery field (combination product).

Job description

  • Determine and write product and user requirements for medical device.
  • Coordinate technical functions though out the design process for system level behavior.
  • Translate requirements into designs that combine hardware, software and mechanics.
  • Write test protocols to verify requirements have been met.
  • Test sub-systems and system-level software.
  • Conduct risk analyses to ensure safe design.
  • Provide Input to automated testing tools.
  • Document procedures and results within the requirements of a medical device quality management system.

Qualifications

• BSc – a must.
• At least 5 years of system engineering experience in medical device industry.
• Product development lifecycle knowledge- A must.
• Understanding of Medical Device design control process.

Senior Mechanical Engineer

Department
Device
Location
Rehovot, Israel

We are looking for an experienced Mechanical Engineer to design our new products and improve existing designs.

Job description

  • Design analysis.
  • Production and assemblies’ drawings including tolerance analysis.
  • Jig design and testing device, including device assembly and test.
  • Preparing production portfolio.
  • Creating work plans and task synchronization of mechanics, electronics and software teams; design review, technical risks, compliance with procedural and documentation requirements.

Qualifications

  • BSc in mechanical engineering – a must.
  • At least 10 years of experience in mechanical design, especially in the field of medical devices.
  • Extensive knowledge in the field of plastic and elastomer design.

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