Director of Quality - SaMD

Position Title: Director of Quality 

Department: Quality and Regulatory 

Reports to: VP of Regulatory Affairs 

COMPANY OVERVIEW 

Remepy is a digital health company specializing in the development of hybrid drugs – a product that includes a traditional pharmacological component and a digital therapeutic app. Remepy’s digital therapeutics applications are developed as Software as a Medical Device (SaMD), in accordance with applicable medical device regulations of the US Food and Drug Administration (FDA) and the International Organization of Standards (ISO). The company is headquartered in the US with R&D operations in Ramat Gan, Israel. As the legal manufacturer, Remepy is responsible for management oversight, regulatory affairs, quality system compliance, document control, design and development, procurement, marketing and sales, complaint handling, manufacturing, and distribution or deployment of its products. 

JOB PROFILE AND DESCRIPTION 

The Director of Quality is responsible for leading Remepy’s 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. 

MAJOR DUTIES AND RESPONSIBILITIES 

• Serve as the primary owner of Remepy’s 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 Remepy’s 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 QMS’s 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. 

PREFERRED QUALIFICATIONS 

• Bachelor’s 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