2. Support and coordinate with other functions to fulfill company’s regulatory tasks mandated by other existing local healthcare regulations, such as the completion of the device registration and tracking monthly reports, the device advertising application, the facilitation of device import exemption and other new regulatory requirement projects assigned by the authority bodies.

3. keep up to date on regulations changes and trends; seek advice on interpretation of government guidelines and regulations to ensure compliance

4. Support and carry out company internal regulatory, quality and compliance processes investigation, recall FDA reporting

5. Track timelines and document milestone achievements, develop regulatory strategy, prioritize strategies/submissions with operating plans as well as ensuring alignment with KOD in country/regions and provide regulatory updates to relevant stakeholders.

6. Provide guidance and feedback to BUs on registration requirements for new and renewal registrations, product and process changes, and review of labeling content and guidance on process improvement projects.

7. Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.

2. Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel

3. Excellent written and verbal communication skills including negotiating and relationship management skills

4. Excellent problem-solving, organizational, analytical and critical thinking skills

5. Full knowledge and understanding of country/regions regulations relevant to medical devices, Class II and/or Class III devices

6. Full knowledge and understanding of country/ regions regulatory requirements for new products or product changes.

7. Good leadership skills and ability to influence change

8. Strict attention to detail

9. Ability to interact professionally with all organizational levels

10. Ability to manage competing priorities in a fast paced environment

11. Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness