Quality Assurance Regulatory Affairs Manager

QA/RA Manager – MedHub-AI

Location: Tel Aviv, Israel

MedHub-AI is transforming cardiology through cutting-edge AI technology. We are looking for an experienced QA/RA Manager to lead regulatory and quality processes, ensuring compliance and successful approvals across multiple global markets.

• Manage regulatory submissions and approvals for FDA (510(k) & De Novo), CE, AMAR (Israel), China, Canada, and Singapore.
• Oversee the transition from MDD to MDR, working with notified bodies and external regulatory affairs agencies.
• Maintain ISO 13485 certification and ensure QMS compliance.
• Develop, review, and execute clinical study protocols, working with external CRAs and site study coordinators.
• Lead interactions with regulatory bodies, including FDA pre-sub meetings and IRB processes.
• Ensure regulatory compliance for Software as a Medical Device (SaMD) products.
• Drive regulatory timelines, ensuring approvals are met within deadlines.

• At least 7 years of experience in regulatory affairs for medical devices, securing approvals in multiple regions.
• Hands-on experience in clinical studies, working with external CRAs, and conducting CRA activities directly.
• Direct experience with FDA pre-sub meetings, IRB approvals, and clinical protocol development.
• Strong background in ISO 13485, QMS maintenance, and certification processes.
• Experience working with notified bodies and regulatory agencies.
• Ability to push regulatory projects forward and meet strict deadlines.
• Relevant academic background in biomedical engineering, regulatory affairs, life sciences, or a related field.
• Professional-level English proficiency (native or equivalent).

• Regulatory experience in cardiology and high-risk medical devices.
• Strong understanding of Software as a Medical Device (SaMD) compliance.

MedHub-AI offers an opportunity to work on innovative healthcare solutions, ensuring they meet the highest regulatory standards. If you have the expertise and drive to lead our QA/RA efforts, we encourage you to apply.