Jing Zhang

Regulatory Affairs Manager

About

Experienced professional with more than 5 years in the medical device industry, specializing in regulatory submissions for active, sterile, standalone software, and IVD devices. Proficient in regulatory requirements for major global markets, including the EU, US, Russia, ASEAN countries, and more. Expertise in distributor registrations across regions such as Brazil, Mexico, Saudi Arabia, Indonesia, Malaysia, Singapore, Tanzania, South Korea, and Taiwan. Successfully established and managed an international regulatory team from the ground up.

Country

United States

City

Newfoundland

Industry

Medical Device

Skill

Regulatory Standards, ISO 10993, Communication, IEC 60601, ISO 13485, MDRs, Regulatory Training, Global Regulatory Compliance, Regulatory Strategy, Regulatory Analysis, Insulin Pumps, Post Market Surveillance, Product Design, Adverse Event Reporting, Regulatory Submissions, Biocompatibility, Product Validation, Medical Device R&D, Medical Device Product Development, Mandarin

Experience

Regulatory Affairs Manager

MicroTech Medical (Hangzhou) Co., Ltd.

2021-3 - Present · 5 yrs 7 mos

Led high-risk product registration projects, including insulin pumps, continuous glucose monitoring (CGM) systems, and closed-loop pumps under MDR and FDA frameworks. Proficient in international performance standards such as ISO 10993 (biocompatibility), IEC 60601 (EMC and Electrical safety), IEC 81001 (cybersecurity), IEC 62366 (usability), and IEC 62304 (software lifecycle). Demonstrated expertise in quality system requirements, including design and development, risk analysis, product validation, and post-market surveillance. Developed MDR compliance strategies and facilitated transitions from MDD/IVDD to MDR/IVDR systems. Maintained strong relationships with notified bodies and regulatory agencies, with proven experience in direct communication and adverse event handling. Conducted regular compliance training sessions company-wide, ensuring up-to-date knowledge of regulatory standards. Directed the international regulatory team in securing market access across Asia, Africa, the Middle East, and Latin America. Provided regulatory guidance to the global sales team, aiding in strategic market access planning.

Regulatory Affairs Specialist

MicroTech Medical (Hangzhou) Co., Ltd.

2019-7 - 2021-3 · 1 yr 9 mos

Responsible for U.S. registrations for blood glucose monitoring systems, successfully obtaining the company’s first FDA 510(k) clearance. Facilitated distributor-led market access in various countries. Assisted with EU surveillance audits and registration of new IVD products.