Principal Officer, Regulatory Affairs

The incumbent will also be responsible for, but not limiting to the following duties:

• Lead domestic / overseas registration cases and get product certificates timely.
• Maintain submission documents and approval documents in related IT systems.
• Provide the regulatory support to cross-functional team within and outside China.
• Provide necessary support to dealers and customers for regulatory compliance.
• Collect, analysis the new released regulations globally.
• Contribute to quality system build-up.
• Participate in product development to ensure compliance to applicable regulations.

This description is a summary of principle responsibilities and is not intended to include all duties may be assigned.

WORKING RELATIONSHIPS AND CONTACTS:

• External contacts for this position include NMPA officials / Overseas health authority officials, dealers and users/customers, local testing center,
• Internal contacts include headquarter, marketing team, logistic team, application and sales/service team, QA, R&D.

ESSENTIAL

EDUCATION & SKILLS:

• Bachelor degree or above.
• Medicine / bioengineering / clinical medicine / biochemistry or pharmacy relevant background is preferred.
• Good English and Chinese language skills

WORKING EXPERIENCE:

This position requires:

• 5 years or above RA working experience in IVD industry.
• Preferably China CDx initial registration experiences.
• Preferably US/EU IVD registration experiences.

FUNCTIONAL COMPETENCIES:

• Expertise in NMPA regulation of IVD and/or medical devices and in NMPA registration process;
• Excellent teamwork and interpersonal communication skill;
• Good attitude, positive thinking & take responsibility;
• Creative thinking for complexed registration cases.

TRAVEL REQUIREMENTS:

This position may require business traveling in a fewness situation.

WORK ENVIRONMENT: 

This position functions in a general office environment.