Regulatory Affairs Specialist

• Establish and maintain the necessary technical documentation for the product registration in Vietnam

• Liaise with counterparts at Headquarters and Vietnam on all registration application issues

• Dialogue with authorities in connection with the registration process in Vietnam

• Timely communication of all authority requests in the required response

• Cooperation and coordination with other departments in strategic and regulatory issues related to the new development and re-registration of medical devices in Vietnam

• Analysis of national and international legal requirements according to medical devices association’s work in the field of medical devices in Vietnam

• Active participation in internal processes and development

• Partner with the project team to ensure the approval at each review gate

• Ensuring personnel and company compliance with local regulations, policies and procedures

• Reporting to the Vietnam Regulatory Affairs Manager (disciplinary) and Greater China & Southeast Asia General Manager Operations and Administration (functional)

• Degree in natural sciences or technology & good technical understanding

• Professional experience in regulatory affairs

• Experience with medical devices (endoscopy preferred)

• Knowledge of relevant national and international medical devices regulations and standards

• Organizational and team skills as well as independent, structured and precise operation

• Very good command of written and spoken English

• Outgoing personality and good communication skills

• Work experience in an international company and understanding of the “Western mindset”