Hope A. Y. Yzryahl

Regulatory Affairs Consultant @ ALKU

About

Accomplished Regulatory Affairs Director and Senior Consultant with over 15 years of global experience supporting Class I-III medical device regulatory strategy and compliance. Proven track record leading FDA 510(k), PMA, EU MDR/IVDR, Health Canada, MHLW (Japan), and MDSAP submissions. Extensive background in Quality Systems (ISO 13485:2016, QSR, MDSAP), CE Marking, risk management, and design control. Well-versed in audits, clinical evaluations, post-market surveillance, regulatory gap assessments, and technical documentation. Adept at guiding cross-functional teams and providing high-level regulatory consulting to global clients.

Country

United States

City

Okatie

Industry

Medical Device

Skill

Accounting, Compliance Management, GxP, Regulatory Development, CMC Regulatory Affairs, Risk Management, Procurement, Regulatory Submissions, Medical Devices, Regulatory Compliance, Auditing, Regulatory Affairs, • Managed QSR, QMS & Regulatory Affairs for Compliance, • Developed the Clinical Evaluation Procedure/Report/Templates, • Created Post Market Clinical Follow-up Procedures/Report/Templates, • Facilitated internal, Supplier and Notified Body Audits, • Trained personnel on EU MDR transition requirements, • EU-MDR Tech File Gap Assessment – Tech File Submissions, Certified Quality Auditor (CQA), Internal Audits