Regulatory Affairs & Quality Assurance Specialist - Abbott Diabetes Care

SUMMARY:

• Focus is on policy and strategy implementation and control rather than development.

• Typically handles short-term operational/tactical responsibilities

MAIN / MAJOR RESPONSIBILITIES

• Support Regulatory Affairs and Quality Assurance activities, including:

• Collect and coordinate information and prepare regulatory documentation for submission, renewal, and/or change

notification to regulatory agencies or to commercial partners in a timely manner.

• Understand country-specific requirements and deliver those to internal stakeholders, including global RA member.

• Communicate with a local health authority to clarify and respond to inquiries as needed.

• Maintain regulatory files/database and chronologies in good order.

• Establish and maintain system for tracking changes in documents submitted to agencies or partners.

• Review labeling and labels for compliance with regulatory requirements.

• Assist in amending/changing the existing local RA/QA SOPs to define the requirements for regulatory submissions or

handing quality matters.

• Maintain knowledge of local regulations, standards, and guidance applicable to ADC’s products.

• Actively participate in evaluation of regulatory compliance document/process/test methods changes.

• Ensure Quality systems are in place that meet the requirements for ADC businesses, local regulatory authorities, and

Abbott Quality Assurance.

• Facilitate to ensure Quality management of Distributors per request.

• Take charge of internal/external QA relevant auditing. Maintain or ensure QA documentation in place.

• Perform other related functions and responsibilities assigned by the supervisor.

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 work

experience.

• Knowledge of regulations and standards affecting medical devices and IVD device

• English proficiency

• Previous working experience in medical device company and dealing with Vietnam Ministry of Health is an advantage