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