Here are our current job openings

We look forward to hearing from you.

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

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.

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

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.

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

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.

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.

We are looking for a QA Operations Manager to support the company’s CMC and supply chain activities, and ensure quality.

Support the CMC development process and activities, be a part of the review and approval process.
Lead or participate in root cause investigations and approve closure of investigations.
Lead or participate in risk assessment processes.
Review and approve executed MBRs, executed packaging BRs, specifications and other supporting documents.
Write various types of documents such as procedures, protocols and risk assessments.

Bachelor’s degree in Life Sciences or equivalent.
At least 5 years of experience in quality systems, in the pharmaceutical or biotech industries.
Knowledge of regulatory requirements.
Fluency in Hebrew and English (written and verbal).

We are looking for a QA Device Engineer to support product development and manufacturing processes.

QA focal point for device projects in design and development processes.
Ensure device compliance with US and EU regulations.
Provide guidance on design, technical and engineering processes/documentation to ensure compliance with procedures, relevant regulations and standards.
Be responsible for reviewing and approving device development DHF and process validation/qualification documentation.
Be responsible for reviewing and approving product design and manufacturing process change controls.
Provide direction, guidance and problem solving for technical and design review activities.
Support QMS activities including: CAPA, failure investigation, non-conformance assessment, internal/external audits, and other assigned duties.

B.Sc. in Engineering or Science.
Minimum 5 years’ experience working in the medical device / pharma industry – in Quality roles.
Experience with medical device design & development, verification/validation activities, risk management, product transfer, DHF activities – an advantage.
Experience in equipment validation, process validation and Change Control process – an advantage.
Deep knowledge of Quality systems such as ISO 13485, 21 CFR 820, ISO 14971.