FUNCTION:

This position will have responsibility to:

• Submit product registration dossier and get approval according to the registration plan, with compliance to regulations and SOP.

• Execute product registration strategy plans in China/US/EU/Other target markets.

• Follow up and interpret Global MD, IVD related regulation updates.

• Establish and maintain good relationship with key contacts such as type testing centers, NMPA and its affiliated organizations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

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

• Complete overseas registration cases and get product certificates according to registration plan.

• 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.

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 QUALIFICATIONS: 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:

• 2 years or above RA working experience in IVD industry.

• Preferably China MD and 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.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.