法規品保經理 R/QA manager - 台北/宜蘭
- 宜蘭縣五結鄉
- 10年以上
- 大學
1.Taking a responsibility of RA&QA teams management, team building, and supervision of team member productivity. 2. Monitoring company complies with domestic and international medical device regulations in all countries that the company is exporting to. 3. Monitoring and setting timelines for maintenance of the company’s QMS. 4. Reviewing company practices and providing advice on changes to QMS. 5. Undertaking and managing QMS internal audit of the company. 6. Playing a role in government affairs to (local) competent authorities or 3rd party. 7. Reviewing labels and packages before product is released. 8. Cooperation with sales & marketing on product position and marketing claims. 9. Reviewing company practices and providing advice on changes to QMS. 10. Prefer : A. Understanding EU MDR 2017/745 and familiar with Directive 93/42/EEC B. Familiar with FDA 510k submission and product listing C. Familiar with Medical device risk management requirements D. Understanding with Medical device Post-Market Surveillance (PMS) and PMCF activities.