Philips Standard Compliance Engineer in Shanghai, China
This position will be responsible for supporting to complete products register and conduct to internal regulatory training to improve current quality activities.
The engineer will work with R&D team members to establish and maintain appropriate systems to ensure regulatory compliance consistent with CFDA, FDA, CE/MDD and other international or domestic laws.
At the same time, the engineer will be responsible for communicate with RA and R&D team on register and relevant regulatory issues.
Providing project leadership for needed updates to existing products caused by new/revised standards, support world-wide regulatory compliance of products, including RoHS, REACH, Risk management, IEC series standard, etc.
Providing R&D engineering support on standard and regulatory issues. Conducting to develop and maintain product standard technical files.
Responsible for recognizing, collecting, updating, maintaining and reviewing external main regulations and medical devices technology standards world-wide, and imbue the regulations and standards at R&D team to ensure the products meet related requirements.
Working closely with RA and R&D team to ensure new products are in compliance with published standards.
Guiding team to transposition of national standards into company product related requirements.
Introducing and explaining the standard clauses to team Organizing team to analysis and share the impact of new/revised standard to VSS products.
Organizing to share the Lesson Learn of standard testing and product design of related standard Tracking and maintaining VSS products’ standard compliance list.
Supporting to deliver Regular Plan of NPIs Test house communication .
Presenting high level new/revised standard status reports on regularly team meeting.
Providing timely information and opinion regarding national regulatory landscape to Management.
Keeping abreast of new/revised regulations, guidelines, compliance guides, inspection reports, journals and meetings of Industry Association etc.;
Other duties as assigned.
Bachelor’s degree, preferably in Engineering, Electro-mechanical, Electronic, or other appropriate technical discipline.
5+ years’ working experience in medical device regulatory, standard or testing / include FDA 510k and CE, CFDA, preferably in medical device industry or household electrical appliances.
Familiar with CFDA, FDA or CE registration procedure and regulations.
Familiar with medical devices technology standard system, such as: IEC/EN, ISO, GB, YY and ANSI-AMMI, etc. standard
Must have strong logistic and analyzing ability, clear thinker.
Must have good problem solving and analytical skills.
Must have good oral and written communication skills (including public presentation skills).
Must be able to communicate effectively with individuals at all organizational levels.
Must be enthusiastic, positive and effective in building working relationships with cross functional teams.
Good verbal and written skills in Mandarin and English.