Profile:Quality and Regulatory Affairs manager with solid academic background and in-depth knowledge and experience in quality assurance management and quality control processes. Implementing proactive quality improvement methods and processes. Setting and implementing quality goals and quality KPIs.Expertise in medical device quality management and regulatory affairs.Working closely with top managers, along with extensive experience in managing people and teams.Overall vision and ability to go into details, assertiveness, technical orientation, and organizational skills. Ability to work on multiple projects in parallel.Hands-on attitude. Skills:• Proficiency with the standards: : CFR 21 Part 820; ISO 13485; EU-MDR 2017/745 ISO 14001;ISO 9001; ISO 14971;ISO 14644; IEC 60601 ; IEC 62366; ISO 11135 ISO 11607; ASTM 4169; ASTM 1980, ISO 10993 • Proficiency with FDA, EU-MDR, Health Canada, PMDA and TGA regulatory requirements raacoh@gmail.com