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 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