Regulatory Affairs Specialist

This role is responsible for preparing of regulatory submissions to the respective FDAs and provide assistance in the implementation of the corporation’s quality goals and objectives.

Responsibilities:
  • Prepare regulatory submissions and interface with the regulators on assigned projects
  • Respond to regulator requests for additional information
  • Keep abreast of changes to the Asia regulatory requirements and International Standards related to our products and processes
  • Review QSR documentation for assigned projects and proposed individual changes to insure compliance with the Company's quality system procedures and determining whether regulatory submissions are required
  • Adapt Standard Operating Procedures to the local market in accordance with local and international regulations
  • Provide Input on Quality Training and Educational initiatives for the local market in accordance with corporate requirements
  • Identify, investigate and close out corrective and preventive actions (CAPA)
  • Participate on the review board for the review and approval of local labeling, promotional advertising and literature
  • Formally communicate regulatory initiatives or changes in the applicable medical device laws with company personnel, customers, subcontractors, regulatory agency representatives, and third party organizations
Requirements:
  • Bachelor degree in Pharmacy, Bioengineering or Life Sciences
  • Over 2 years of experience in Vietnam and ASEAN regulatory requirements and submissions
  • Proven skills in conducting research on Worldwide Web for regulatory, guidelines, etc.
  • Proficiency in written and spoken English
  • Self Motivated, attention to detail and flexible

 

If you meet these criteria and have a passion to join a business where you can grow your career as the business grows, please go to our company website and apply the job in Dentsply: https://dentsplysirona.com/en/career/job-opportunities.html