Senior Regulatory Affairs & Compliance Specialist
On-site · Beijing, Beijing, China
Job Summary
Senior Regulatory Affairs & Compliance Specialist for Abbott Rapid Diagnostics covering Mainland China and Hong Kong. Responsible for fast and efficient registration and listing dossiers, submission based on product launches, and coordination with legal/RA for type testing documentation. Performs registration-type testing per planned registrations; communicates registration regulations to RA and trial teams; ensures product labelling complies with NMPA requirements; collects and submits periodic risk evaluations to local regulatory authorities; collaborates with RA and clinical trial teams. Must have very accountable, detailed working attitude with high integrity and teamwork; proficient in English and Microsoft Office; base pay varies by location; located in Beijing, China. 2+ years of medical device registration experience in China for imported products and IVD experience is preferred.
Required Qualifications
- Bachelor’s Degree of Medical related major
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