Job description

• Manage the lab team and ensure they are qualified and well trained.
• Guide and mentor the lab team for best practices.
• Define and implement processes and tools for managing and monitoring lab tests.
• Ensure and enforce lab safety.
• Manage lab tests from initial request to final test documentation.
• Drive continuous improvements in lab processes and test methods.
• Ensure availability of samples, materials and tools required for testing.
• Define and manage the lab budget.

Qualifications

• Bachelor's degree in Engineering or equivalent
• At least 3 years of experience as a lab manager
• Experience in team management
• Fluency in Hebrew and English

Job description

• Define and establish mechanical and electronic development, from idea to production, including architecture, technologies, problem solving, failure investigation, detailed design, verification testing and samples manufacturing.
• Manage the mechanical and electronic development team, its activities and subcontractors, in keeping with timelines and budgets.
• Be responsible for compliance with relevant regulatory and quality requirements (FDA and ISO).

Qualifications

• Bachelor's degree in Engineering or equivalent.
• At least 5 years of experience in managing a mechanical design and mechanical engineering team.
• Experience in developing departmental strategies and processes.
• Strong technical experience and background in some of the following fields: Plastics and injection molding\ Elastomers and seals design\ Mechatronics design\ Complex system design.
• Fluency in English and Hebrew.

Job description

• Receive requirements from R&D and System Engineering and ensure they are defined to allow testability.
• Create verification protocols and reports within the requirements of the medical device quality management system.
•  Lead execution of testing by monitoring preparation, progress and risks, and be the professional focal point for sub-contractors.
•  Perform and present statistical analysis on collected data.
•  Define requirements for software tools, fixtures and equipment required to execute test methods.
• Document out-of-specs and deviations, analyze data and run initial failure analysis investigations with hand-off to System Engineering.

Qualifications

• Bachelor’s degree in engineering.
• 3 or more years of experience in the medical device industry.
•  Experience in multidisciplinary project management – an advantage.
• Experience in R&D and design verification.
•  Knowledge of Office tools and statistical tools.
•  Fluency in English, both verbal and written.

Job description

• Managing the combination product’s quality system.
• Supporting the device development process; including design definition, risk management activities, process meetings and design reviews.

Qualifications

• Bachelor's degree in Engineering or equivalent.
• At least 5 years of experience in establishing and maintaining combination product or medical device quality management. Including, but not limited to, medical device design and development process (including software), supplier qualification, CAPA, non-conformance and change controls.
• Fluency in Hebrew and English.

Job description

Responsibility for preparation and submission of branded drug-device combination in EU and US regulatory authorities:

• Establish and maintain infrastructure for file preparation and submission.
• Leading the cross-functional NDA project team.
• Manage consultants and subcontractors, as needed.
• Facilitate interdisciplinary agreements on file submission content.
• Gap analysis to ensure quality submission and compliance with regulatory requirements /commitments to regulatory authorities.
• Overview and integration of submission content.
• Track, interpret and advise on applicable US and European regulations, guidelines, procedures and policies.

Qualifications

• Global regulatory experience and current knowledge of FDA Guidelines – A must.
• Experience in global pharma.
• Proven Project management capabilities.
• Leadership without authority.
• Excellent interpersonal skills.
• Experience with drug-device combination products – an advantage.

Job description

• Compilation of the submission package in collaboration with the relevant functions (CMC, pre-clinical, clinical, device).
• Follow up with CRO/clinical operations to ensure on-time quality submission.
• Regulatory Intelligence - Track, interpret and advise on US and European regulations, guidelines,
• procedures and policies within the scope of the company, with a focus on the clinical discipline.

Qualifications

• 2-3 years of experience in RA
• Experience in the pharma industry
• Fluency in Hebrew and English