Xingwen Chen Email and Phone Number
More than 15 years experience in medical device and relative regulatory affairs with an emphasis on home healthcare Respiratory Equipment (Class 2 device) both in the US (author of seven 510k) and CE-marking(leader of more than ten products) to the MDR.Graduated in Robotic and mechatronic engineering, I had been a R&D engineer and Manufacturing Engineer in a Danaher company in Industry Instruments fields. Familiar with QSR820, ISO13485, Passed un-announced audit by FDA Inspector in 2014 and routine QS audits by NB. I am actively involved in developing ISO standards of medical device and transferring them into Medical field standards of China.Member of ISO TC121 workgroup.Member of ISO TC215 workgroup.Member of SAC TC221 workgroup.Member of SAC TC10/SC5 workgroup.Member of SAC TC116 workgroup.
Bmc Medical Co., Ltd
View- Website:
- bmc-medical.com
- Employees:
- 71
-
Technical DirectorBmc Medical Co. Ltd. Dec 2023 - PresentBeijing,China
-
Sr. Manager Of Global Regulations & StandardsBmc Medical Co., Ltd Jan 2019 - PresentBeijing City, ChinaCurrently, as a Sr. Manager of Global Regulations & Standards , my work focus on Regulatory Affairs and product standards compliance since the start of medical device lifecycle. Follow up FDA/NMPA/EU regulations and guidelines closely to assure company’s products are well under compliance. Interact with officials of CFDA where necessary for registration and regulatory affairs. Solve the controversial problems in the type inspection of Medical device as an advanced expert. Maintain the good communication with the domestic test labs and Notify bodies. Develop product related international and SAC standards and research, participate in the regulations and standards groups and meetings of domestic regulations and standards development.
-
Management Representative, Ra & Qa ManagerBmc Medical Jan 2018 - Jan 2019Focuses on the regulation compliance of headquarter, Insight on policy changes, to assess the regulatory impact for the company business and make strategy adjustment proposal. Provide advice to Top management for practical operations oriented interpretation of Regulatory requirements.Internal communicate with respective teams to assure they know the regulation changes and understand what are necessary when it comes to regulatory and risk management.Follow up NMPA/EU/FDA regulations and guidelines closely to assure company’s products are well under compliance. Interact with officials of NMPA where necessary for registration and regulatory affairs.Train and coach team for RA and QA perspectives.
-
Manager Of Regulation Affairs DeptBmc Medical Jan 2015 - Jan 2018Manage the product lifecycle registration and laws compliance, for global market area in US, EU, Brazil, Korea, Russia, and some other countries. Provides Top management practical operations oriented interpretation of Regulatory requirements in Manufacturing site change, contract manufacturing, Operation.Proactive involvement on researching FDA Cyber-security, ISO 18562 standards, NMPA software guidance , driven FDA UDI compliance implementation , deal with other CFDA and EU regulation affairs in medical device field.
-
Manager Of R&D Administration And Regulation ComplianceBmc Medical Co., Ltd Apr 2013 - Jan 2015Design Control improvement; focus on design change and new products compliance, based on IEC/ISO standards, and FDA guidelines, to Upgrade existing products for better lifecycle. Leader of 2 FDA 510K applications (emphasis on APP software and cyber-security), since 2013-2016. Lead the RoHS project into company quality system and set up the SOPs.Lead human factor engineering research and Clinical trials of 2 projects.
-
Manager, R&D Dept.Bmc Medical May 2009 - Mar 2013Leader of BPAP and Mask, apply for relative 2 FDA 510Ks, since 2011. Lead research and develop about sleep apnea therapy device and masks. Build 10 persons R&D team.
-
Manufacture EngineerFluke Corporation Feb 2006 - Apr 2009 -
Electrical EngineerHollysys Automation Technology Aug 2003 - Jan 2006Instrument design. focus on hardware and embbeded software, field bus in Profibus-DP.
Xingwen Chen Skills
Xingwen Chen Education Details
-
Mechatronics, Robotics, And Automation Engineering
Frequently Asked Questions about Xingwen Chen
What company does Xingwen Chen work for?
Xingwen Chen works for Bmc Medical Co., Ltd
What is Xingwen Chen's role at the current company?
Xingwen Chen's current role is Technical Director （Regulations & Standards） BMC Medical Co., Ltd.
What schools did Xingwen Chen attend?
Xingwen Chen attended Tianjin University.
What are some of Xingwen Chen's interests?
Xingwen Chen has interest in Health, Economic Empowerment.
What skills is Xingwen Chen known for?
Xingwen Chen has skills like Medical Devices, R&d, Regulatory Affairs, Design Control, Manufacturing, Iso, Usability Engineering, Iso 13485, Fda, 跨职能团队领导力, 质量管理体系, Microsoft Office.
Who are Xingwen Chen's colleagues?
Xingwen Chen's colleagues are Manal Moumni, Edivânia Santos, 汪海生, Ashley Ma, Albert Huang, 姜晓辉, Ana Yuan.
Not the Xingwen Chen you were looking for?
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial