Technical Leader, Regulatory Verification

Job Responsibilities 1) Main tasks: • Support China registration for active medical devices, mainly focus on the type testing related tasks • Be the bridge of national lab and global experts, collect the test methods or reports to fulfill the type test requirement of China NMPA; • Work with China RA and global experts, prepare the dossiers like PTR (Product technical requirement), CER (Clinical evaluation report), innovation reports, etc. • As the technical expert of Global and China standards, participate in China standards and NMPA guidance drafting and discussion, protect the product and market of FMC. • Organization and execution of product verification of medical products, accessories and modules. • Creation of associated verification documents acc. to internal and external requirements, and ensure such documentation is audit-proof • Coordination of necessary verification measures in the design change process • Be a professional at test method design, samples preparing, operating, debugging & simulating according to the project needs, especially for standard related testing • Responsible to medical device EMC test • Responsible to conduct wireless module RF compliance test with 3d party 2) Secondary tasks: Tasks performed regularly in addition to the main duties but which do not determine the essential character of the position. 3) Miscellaneous tasks: • Internal and external requirements (such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-16 etc.) • Familiar with basic EMC and wireless knowledge, preferably with relevant EMC and RF test experience • Familiar with EMC and wireless related standards (Such as IEC61000, CISPR11, EN300 328, EN301 893 etc.) • Strong technical support to RF and EMC test system building • Creation and approve submission documentation and keep them quality compliance. • Strong technical support to the Team, Method and Lab Running • Be a Coach for R&D internal employees for product (HD etc.) technical Introduction & Training. Qualifications, experience, know-how and skills critical for success* 1) Required training and education: BS or MS in EE/ME/BM Engineering or related filed 2) Required professional experience (in years): • Minimum 8 years in Medical R&D related area (Prefer HD area) • Minimum 5 years in EMC test area (Prefer medical device) • Minimum 5 ears in RF performance test area (Prefer2.4GHz and 5GHz frequency scope) 3) Important personal qualities: • Ownership & Responsibility • Hard working, focusing on Quality & Details. • Team player, good communicator 4) Other specialized knowledge: a) Technical knowledge • Familiar with QMS related standard (ISO 9001, ISO 13485 etc.) • Familiar with IEC, GB and YY standards, like IEC60601-1, GB 9706.1 and YY0505, IEC61000, CISPR11, IEC60601-1-2, EN300 328, EN301 893, etc. • Proficient in using basic test instruments (such as multimeter, oscilloscope, signal source, spectrum analyser, network analyser, etc.) • EMC debug experience is a plus • ISO 17025 experience is a plus b) Languages • Strong English verbal and written communication skills c) IT skills • Have excellent skills with general computer use and office applications such as Microsoft Word, Excel, and Power point. d) Product knowledge • Familiar with medical device industry and knowledge of HD dialysis machine is preferred 5) Special personal requirements: • Willingness to travel if business required and • Be comfortable working in a global organization • Be comfortable working under pressure