Job Responsibilities :

• Responsible to lead the RA team
• Review medical device labeling (product labels, IFU and promotional material) for compliance with applicable regulations and technical standards.
• Edit and review technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents submissions in USA, Canada and Europe.
• Work with delegate to prepare submission documents for medical device registration in specific countries.
• Make sure all materials required in submissions, license renewal and annual registrations complied with national regulatory.
• Register and keep maintenance of products’ licenses in responsible countries
• Take leadership in clinical evaluation and post-market surveillance activities
• Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.
• Provides the most updated Regulatory guidance and standards to cross functional departments and ensures the interpretation of the guidance and standard is correctly delivered and implemented across the organization.
• Stay abreast of QMS procedures per the updated the regulatory requirements on time;
• Support other regulatory topics in collaboration with cross-functional team
• Required to station in Songshan Lake office 5 days per week.

Requirements :

• University graduate in Science, biomedical engineering, or Medical-related field.
• Minimum 4 years of experience in medical device regulatory affairs, quality, or engineering
• Knowledge of FDA, EU, NMPA regulation for medical devices, guidelines, and standards.
• Experience with respiratory medical device is taken advantage
• Fluency in English and Mandarin, orally and in writing
• Effectively collaborate with technical and marketing department

Attractive remuneration package is provided to the right candidate, including 5 day work, incentive bonus & medical insurance. Interested parties please send your full resume with CURRENT and EXPECTED salary by clicking "Apply Now".