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
Ngành nghề: Y tế / Chăm sóc sức khỏe / Thẩm mỹ / Làm đẹp
Kinh nghiệm: 3 Năm
Cấp bậc: Nhân viên
Hình thức: Nhân viên chính thức
Địa điểm: Hà Nội