Min Zhou

- provide support to clients in the medical device industry in (re)writing of clinical and regulatory strategies, authority communications (notified bodies, regulatory authorities), improving technical documentation, improving their quality system or doing audits mainly for China, EU and USA market access - provide training both in-house and publicly, proactively follow the news and trends in the market to share through company blogs, presentations or similar to promote the knowledge and company brand

- responsible for product registration, approval of variation and certificate renewal in China for medical device product - develop strategies and create regulatory submissions for worldwide governmental approval to introduce new products (class I to class III medical device products) to market and maintaining existing products certificates, such as, CE marking, ARTG certificate in Australia, Gost certificate in Russia, 510(k) etc., - support audits - support regulatory compliance activities - manage team

- establish and maintain quality management system according to ISO 13485 and NMPA requirements - create SOPs for design control procedure and risk management control procedure, etc. - responsible for passing the GMP/QMS audit conducted by NMPA and Notified Body - prepare regulatory submissions including, risk management report, pre-clinical studies reports, justification for the representativeness of type test sample, etc., for getting registration certificate from NMPA - conduct supplier audit

- involved in QC activities, such as conducting statistical process control (SPC) on key manufacturing processes - responsible for customer complaint treatment, including segregation of affected products, cause analysis, corrective actions follow-up, finalizing 8D report and communicating with customer, etc. - conduct internal audit, and coordinate audit conducted by customer. - monitor and report quality status regularly