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.
Skills Required
- Bachelor's degree or higher
- Medicine, bioengineering, clinical medicine, biochemistry, or pharmacy-related educational background
- Good English and Chinese language skills
- At least 5 years of regulatory affairs experience in the IVD industry
- China CDx initial registration experience
- US/EU IVD registration experience
- Expertise in NMPA IVD and/or medical device regulations and registration processes
- Strong teamwork and interpersonal communication skills
- Creative thinking for complex registration cases
Danaher Corporation Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Danaher Corporation and has not been reviewed or approved by Danaher Corporation.
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Healthcare Strength — Healthcare coverage is described as comprehensive, including medical plan options alongside dental, vision, life, disability, and mental health support. Wellness initiatives and support programs such as an EAP and vaccination or fitness offerings add breadth beyond core insurance.
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Retirement Support — Retirement benefits include a 401(k) plan with employer matching and options such as pre-tax and Roth contributions. Broader financial rewards such as performance bonuses and access to equity or an employee stock purchase plan are also described.
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Parental & Family Support — Parental leave and family-building support are described as available, including maternity and paternity leave and fertility assistance. Childcare and eldercare support are also highlighted as part of the overall package.
Danaher Corporation Insights
What We Do
Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. A global network of more than 25 operating companies, we drive meaningful innovation in some of today’s most dynamic industries through our operating companies in four strategic platforms: Life Sciences, Diagnostics, Water Quality and Product Identification. The engine at the heart of our success is the Danaher Business System (DBS), a set of tools that enables continuous improvement around lean, growth and leadership. Through the ingenuity of our people, the power of DBS and the impact of our meaningful technologies, we help realize life’s potential in ourselves and for those we serve.
