Amanie Yazidi

WORK HISTORY

EDUCATION

ABOUT AMANIE YAZIDI

I am more than just a woman, a mother, a child, a sister, a friend, and a lover; I have dedicated 20+ years to the field of Medical Devices. My everyday commitment is to enhance the quality of patients care by being part of teams that transform innovations into high-performance and accessible products.I am driven by compliance, creativity, and the ability to understand industry and business needs.I feel passionate participating in meaningful changes in the world, regardless of the size of my contribution.My most significant experiences:• Team Leader: Expertise in hiring, onboarding, skills development and people growth.• Medical Devices Design and Development (new devices and change management): Involvement in activities from a Quality Assurance and Regulatory Affairs perspective, along with project management.• Quality Management Systems: Proficient in all facets related to QMS, with extensive knowledge of Medical Device regulations, including 21 CFR, MDR (EU) 2017/745, ISO 13485, and various country-specific requirements (Japan, Canada, Brazil, Taiwan, and Korea).• Regulatory Submissions: Experienced in submitting regulatory files for several jurisdictions, including US 510(k) premarket approval, CE marking in Europe, and submissions for several markets (Brazil, Taiwan, Japan, Korea, and the Middle East).• Audit and Inspection Management: Skilled in coordinating and reviewing technical files, managing third-party audits, and internal audits, including supplier audits.• Technical Standards expertise: such as ISO 14971, IEC 62304, IEC 62366-1, IEC 60601-1, and ISO 10993-1.• Training and Support: Provide training and support to internal stakeholders and customers.• Testing Laboratory Quality Management: successful experience through ISO 17025 implementation.• Sterilization Processes: High experience with Ethylene Oxide sterilization processes.