Specialist, Regulatory Affairs

• 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.