Principal Officer, Regulatory Affairs

Job description

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. Establish and execute CDx registration strategy plans in China/US/EU/Other target markets. Participate in product design & development, work with Pharma Partners to drive the “Drug – Diagnostic Reagent” co-development projects. Follow up and interpret Global MD, IVD & CDx related regulation updates.

Support registration / regulatory activities about GMP / ISO 13485 quality system build up / maintenance. 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: 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 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: 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. 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 .