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Gyntools Israel - Jerusalem - Full time - Immediate

QA&RA manager

The “hands-on” Quality Assurance and Regulatory affairs manager is responsible for driving the Quality and Regulatory vision and plans to execute company quality objectives, metrics, reporting and operating mechanisms, establishing & implementing the regulatory best practices, technical standards, laws and regulations, regulatory programs.

  • Accountable for ensuring full quality and regulatory compliance of a facility including having solid QMS in place, while driving process effectiveness and efficiency at the site.

  • Ensures site audit readiness and hosts the Quality System audits; prepares and executes Quality Management System reviews.

  • Proactive identification and alerting of quality issues in time to resolve potential adverse effects to the customer.

  • Define approach and governance quality system internal audit program including training of auditors.

  • Owns site compliance assessment and remediation plans while influencing site execution, functional policy, local research and development programs, and communications and training requirements for Quality matters.

  • Drive continuous improvement of Supplier Quality functional competence and maturity through coaching, mentoring and promotion of best practice. 

  • Analyze and communicate regulatory trends and their implications for the site; develop & implement effective regulatory strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements and acts as PRRC (Person Responsible for Regulatory Compliance).

  • Lead and support continuous improvement activities, including such areas as regulatory procedure development and documentation, standards compliance, metrics development and implementation.

  • Product verification & testing

  • Lead analytic tests

  • Bachelor’s degree in Engineering or life sciences.

  • Minimum 3 years Quality Assurance/Regulatory experience as QA/RA manager in 
      a medical device company. (medical diagnostics preferred).

  • Demonstrated knowledge of regulatory issues, and experience interfacing with local &   international regulatory bodies, such as FDA, European competent authorities & notified   bodies, Health Canada, etc.

  • Experience of routine QA/QC activities: CAPA, MRB, ECO, RMA, SCAR.

  • Demonstrated management skills; ability to prioritize, plan, evaluate & execute
      deliverables for established tactical goals.

  • Technical understanding and hands-on skills

  • Ability to lead analytic tests.

  • Demonstrated knowledge of Quality Management System tools, continuous improvement
      methodologies & in-depth understanding of site level products & related processes.

  • English Proficiency

  • Dedicated, organized person.

Please send CVs to


Duties and responsibilities

Required qualifications

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