The Director of Quality is responsible for leading Quality Management System execution for digital therapeutics and Software as a Medical Device (SaMD) products. This critical leadership role ensures our products meet the highest standards of safety, efficacy, and compliance across the entire product lifecycle. You will play a key role in shaping and maintaining the QMS, establishing and driving operational excellence, and supporting regulatory submissions, with a focus on continuous improvement and cross-functional collaboration.
Work Environment
This role is based in our office in Ramat Gan, offering the opportunity to collaborate closely with our dynamic team in person.
Responsibilities
Serve as the primary owner of Quality Management System (QMS) for SaMD, ensuring compliance across the product lifecycle and acting as the main point of contact for all quality-related matters.
Serving as the internal lead for Document Control and Employee QMS Training, and maintaining procedures and records; support future transition to eQMS, including validation when required.
Collaborate cross-functionally with Product Management, Engineering, Project Management, and Clinical teams to write and compile technical documentation and Design History Files (DHFs) for regulatory submissions.
Ensure regulatory compliance and provide oversight by implementing and maintaining adherence to GMP, FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and other applicable global and local standards. Translate regulatory requirements into efficient internal processes.
Manage post-market surveillance activities such as customer complaint handling, nonconformance investigations, CAPA processes, and regulatory reporting.
Maintain audit and inspection readiness, and lead or support inspections by regulatory agencies (FDA), notified bodies, partners, or other stakeholders.
Provide leadership in risk management by guiding cross-functional teams in creating and maintaining risk management documentation, including hazard analyses, design/user risk assessments, cybersecurity risk assessments, risk management plans and reports, and risk control implementation.
Lead continuous improvement initiatives to enhance the QMSs effectiveness and efficiency, including defining and tracking KPIs, identifying trends, and delivering actionable insights to leadership.
Oversee supplier management processes, ensuring supplier qualification, validation, and continuous monitoring of software suppliers and service providers to maintain regulatory compliance.
Contribute to the preparation and review of regulatory documentation, ensuring submission content is clear, consistent, and aligned with relevant standards and expectations.
Promote a culture of quality throughout the organization by delivering employee training programs and fostering quality awareness and ownership across all teams.
Requirements: Bachelors degree in life sciences, engineering, or a related field
10+ years of experience in the medical device industry; SaMD experience highly preferred
In-depth knowledge of GMP and quality and regulatory frameworks, including ISO 13485, FDA 21 CFR Parts 820 and 11, IEC 62304, IEC 62366, and ISO 14971; EU MDR is a plus
Knowledge of software development process and agile methodologies is a plus
Proven track record in QMS ownership, document creation, audit leadership, and post-market QMS activities
Strong interpersonal and communication skills, with the ability to convey technical concepts and regulatory/quality requirements clearly
Ability to manage multiple priorities in a fast-paced, collaborative environment
This position is open to all candidates.