About the role--

1. Write, analyze, and edit technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.

2. Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required.

3. Stay abreast of regulatory procedures and changes in regulatory climate.

4. Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.

5. Review product labels and promotional material for compliance with applicable regulations and technical standards. Create IFUs.

6. Plan and monitor regulatory testings and validation. Support timeline of the new product launches.

7. Provides Regulatory guidance to departments or development project teams regarding design, development, evaluation, and marketing of products, and ensure the interpretation of the guidance is correctly delivered and implemented across the organization.

8. Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.

9. Once a week in Suzhou per month and 3-4 days in Foshan per month for onsite regulatory management and trainings. 10. You may be responsible for the submission of particular products or be an advisor of other RA Officer’s submission.