Quality Assurance Regulatory Affairs Manager

• Serving as the QA & Regulatory Affairs (QA/RA) Lead / Manager, taking complete ownership over Quality Management Systems (QMS) and global regulatory compliance across the product lifecycle.
• Driving international regulatory submissions and market clearance strategies, including FDA (e.g., 510(k)) and CE Marking (EU MDR), guiding the diagnostic platform toward commercial launch.
• Managing, maintaining, and continuously evolving the company's Quality Management System in strict adherence to ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• Partnering with cross-functional R&D squads across Hardware, Software, Optics, and AI to enforce Design Controls, Risk Management, verification, and validation (V&V) protocols.
• Directing internal and external regulatory audits, overseeing corrective and preventive actions (CAPA), root-cause investigations, and non-conformance management.
• Establishing supplier quality frameworks, managing contract manufacturing quality audits, and monitoring incoming/in-line production controls.
• Architecting Post-Market Surveillance (PMS) plans, customer complaint handling mechanisms, and vigilance reporting workflows for global market deployments.

Requirements -

• Bachelor's degree (B.Sc.) in Biomedical Engineering, Biotechnology, Life Sciences, or a related technical discipline – Mandatory
• At least 6 years of proven professional hands-on experience in QA / RA roles within the Medical Device industry – Mandatory
• Demonstrated experience working with multidisciplinary medical devices combining hardware, embedded systems, and software (SaMD / SiMD) – Mandatory
• Deep, authoritative mastery of medical device regulatory standards: ISO 13485, ISO 14971, FDA 21 CFR 820, and EU MDR – Mandatory
• Proven track record of successful regulatory submissions, including FDA 510(k) clearances and CE mark approvals – Mandatory
• Extensive hands-on experience in QMS maintenance, internal/external audits, Design Controls, Risk Management, and CAPA lifecycle execution – Mandatory
• Hands-on experience collaborating with active production and assembly environments, including supplier quality oversight – Mandatory
• Full-time commitment to working on-site from the company’s office in the Sharon region – Mandatory
• Fluent, professional technical communication, audit-defense, and submission-writing capabilities in English (written and verbal) – Mandatory