Senior QA/RA Manager | Medical Device Industry

Senior QA/RA Manager | Medical Device Industry
📍 Location: Haifa, Israel
A leading medical device manufacturing company, developing innovative products for global markets in a multidisciplinary environment, is seeking an experienced Senior QA/RA Manager to lead the Quality Assurance and Regulatory Affairs functions.
This is a key leadership role with end-to-end responsibility for the company's Quality Management System, regulatory compliance activities, audit readiness, and collaboration with cross-functional teams throughout the product lifecycle.
Key Responsibilities:
🔹 Lead and manage the company's Quality Assurance and Regulatory Affairs activities in compliance with FDA, ISO 13485, MDR, and MDSAP requirements.
🔹 Maintain, improve, and ensure the effectiveness of the Quality Management System (QMS).
🔹 Prepare, review, and submit regulatory documentation, product registrations, licenses, and regulatory filings.
🔹 Monitor evolving global regulatory requirements and assess their impact on existing and future products.
🔹 Lead external audits, including FDA inspections, ISO certification audits, and Notified Body assessments.
🔹 Manage company certifications and ensure continuous regulatory compliance.
🔹 Oversee CAPA processes, nonconformance management, customer complaints, post-market surveillance (PMS), and risk management activities.
🔹 Serve as the company's Management Representative and PRRC in accordance with EU MDR requirements.
🔹 Partner closely with R&D, Engineering, Manufacturing, and Operations teams to integrate quality and regulatory requirements throughout product development and commercialization.
🔹 Drive a culture of quality, continuous improvement, and operational excellence across the organization.