Job Title:  Senior Executive - Regulatory Affairs & Quality Assurance

Short Description

The Senior Executive – Regulatory Affairs & Quality Assurance provides support to the strategic leadership and will handle the following activities: 
 

Job Responsibilities:

•    Manage the market access approval proactively to allow “as early as possible” product launching including: 
    - Product registration for new product introduction
    - The variation, licenses retention and post market regulatory management for business support
    - Registration database maintenance to ensure accurate and up-to-date record filing
•    Manage contacts with local authorities for regulatory issue. 
•    All activities related to the RA/QA review, approval, escalation, impact-analysis, problem-solving and risk mitigating process of New Product Introduction and manage the product design change. to existing products.
•    Remain up to date on regulations and communicate any key changes to stakeholders in the broader organization
•    Participate in and/or support various multi-functional teams and projects to ensure compliance to regulatory requirements for the designated sales areas.
•    Operationally manage and control the activities related to the development, maintenance, continuous improvement, simplification and compliance of CDAKB Quality Management System(s).
    - Serve as Technical Person
    - Create, review and approve the SOP, Work Instruction and other quality documents cross-departmental.
    - Lead and provide support during internal and external audits. Supervise, manage and close internal and external non-conformities.
    - Participate in post-market surveillance activities as necessary.
•    Oversee the activities related to supplier management for quality management system. 

Job Requirements:

•    At least Diploma (D3) in Pharmacy, Medical Engineering or College Degree in Electrical Engineering, Biomedical Engineering or equivalent
•    Possess adequate knowledge of business processes / procedures related to RA & Product Registration, regulatory frameworks and requirements in the designated country(s) for Medical Devices.
•    Knowledge and understanding of national regulations on CDAKB
•    Basic knowledge of the regional and international Medical Device Regulation and/or medical device related (international) standards will be highly advantageous but not mandatory
•    Proficient in English
•    Good knowledge of MS Office
•    Open to hire Executive/Senior Executive level, depending on experience