Regulatory Affairs & Quality Assurance Specialist - Abbott Diabetes Care (Medical Devices)

SUMMARY:• Focus is on policy and strategy implementation and control rather than development.• Typically handles short-term operational/tactical responsibilitiesMAIN / MAJOR RESPONSIBILITIES• Support Regulatory Affairs and Quality Assurance activities, including:• Collect and coordinate information and prepare regulatory documentation for submission, renewal, and/or changenotification to regulatory agencies or to commercial partners in a timely manner.•...

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED• Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy,pharmacology), math, engineering, or medical fields is preferred. Or an equivalent combination of education and workexperience.• Knowledge of regulations and standards affecting medical devices and IVD device• English proficiency• Previous working experience in medical device company and dealing with Vietnam...