We’re looking for a highly experienced, versatile, and passionate QARA Specialist to join our amazing Medical Company's NPD QA&RA department. In this role you will have an opportunity to lead and impact product Quality that improves millions of people's health globally.
• Leading processes for R&D projects by developing and maintaining the regulatory strategy for new products
• Maintaining product compliance with Global Regulations and Standards
• Leading product certificate renewal and new product registration Worldwide, in accordance with EU MDR, FDA, PMDA, NPDA guidelines and requirements
• Leading product development processes in accordance with QMS requirements, external and internal standards, and regulation guidelines thorough the product life cycle
• Updating QMS procedures
• Reviewing and approving DHF documents
• Supporting Risk Management and Defect Management activities
• Leading internal and external audits
• Leading continuous efficiency and improvement activities of existing processes
• A Bachelor's degree - mandatory (Engineering degree is an advantage)
• At least 5 years of experience in QA or RA positions in the Medical Device industry
• Knowledge of Medical Device Regulations, Quality Processes and Standards: 21 CFR, MDD / MDR, CANADA SOR, ISO 13485, ISO 14971, ISO 9001, IEC 60601-1, IEC 60601-1-2; IEC60601-1-6; IEC62304; ISO 14001; China and Japan regulations
• Experience in accompanying external and internal audits
• Internal Auditor Certificate - an advantage.
• Excellent English - verbal and written communication skills