Senior QA / RA Manager for a Medical Device Company

A key role involving full responsibility for the quality and regulatory fields within the organization, working with international regulatory and certification bodies, and leading audits and certification processes.

• Leading the quality and regulatory system in accordance with FDA, ISO 13485, MDR, and MDSAP requirements.
• Management, maintenance, and continuous improvement of the Quality Management System (QMS).
• Responsibility for the preparation and submission of regulatory documents, product registrations, and licenses to authorities and certification bodies.
• Monitoring regulatory changes and implementing them within the company's activities.
• Managing and leading external audits, FDA audits, ISO, and Notified Bodies audits.
• Leading certification processes and maintaining the company's and products' approvals in various markets.
• Responsibility for CAPA processes, deviation management, customer complaints, PMS, and risk management.
• PRRC role in accordance with European MDR requirements and serving as management representative in the quality field.
• Routine work with R&D, engineering, manufacturing, and operations departments to integrate quality and regulatory requirements throughout the product lifecycle.
• Leading improvement processes, implementing a quality culture, and supporting the company's business and strategic goals.

• 10 years or more of experience in QA / RA roles in the medical device industry.
• Significant managerial experience and leading teams and cross-organizational processes.
• Deep knowledge of FDA, ISO 13485, MDR, and MDSAP standards.
• Experience working with international certification and regulatory bodies.
• Experience leading audits and certifications.
• At least a Bachelor's degree in a relevant field.
• Professional certifications in the quality and regulatory field will be an advantage.
• Very high level of English.