Job Description：

Company Background:

• A leading American company.




Key Responsibility:

• To responsible for product registration on assigned segment.

• Track new regulations / standards or changes health agencies and evaluate the business impact. Provide interpretation of regulations and requirements.

• To provide relevant RA work for database maintains and documentation archive.

• To assist and support RA supervisor for related project strategy analysis and implementation.

• Participate in the development of regulatory affairs strategy and action plan.

• Compile registration dossier and ensure timely regulatory submission upon internal review and approval.

• Communicate with regulatory agencies/institutes (e.g., CFDA, PFDA, CDE, NIFDC, CPC, Coast Drug Control Institutes) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.

• Timely/closely monitor regulations and review process for ensuring the data presented fully represent what is practically required and the constantly changing regulations to be followed.




Key Qualification:

• Bachelor degree or above in Biomedical Engineering or related sciences.

• Above 2 years working experience in the field of medical devices.

• Professional knowledge on regulatory affairs field.

• Computer skills and be proficient with commonly used software.

• Good at written and oral in English.