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.

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. 

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.

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.

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 science or mechanical engineering disciplines.
• At least 5 years of relevant experience.
• Extensive knowledge in applicable regulations, including EU and US.

Job description

• Ensure project plans / timelines are on track and aligned with company targets.
• Monitor and timeline product development processes, regulatory submission, pre-launch preparations and product launch.
• Develop a holistic view and help resolve cross-functional issues and roadblocks in projects.
• Manage team meetings including capturing action items/ decisions and tracking completion.
• Report any risks to timeline objectives to head of PMO.

Qualifications

• Scientific or engineering degree; BSc or MSc in Biology, Biotechnology, biomedical engineering or industrial engineering.
• 5-7 years of PMO experience in the pharmaceutical industry.