Boston Scientific Regulatory Affairs Specialist 

Thailand, Bangkok, Bangkok 

578403953

Key Responsibilities:

• Provides input on regulatory-related issues associated with compliance and achieving the business plan.
• Preparing, compiling and submitting regulatory applications to the local health authority.
• Input and properly maintain all regulatory databases.
• Ensure product registrations are reviewed and renewed as required.
• Ensure product change/ amendment are approved in timely manner and work with relevant stakeholders to minimize business disruption
• Ensure any other compliances such as labeling requirement, promotional material, any other reporting
• To keep abreast of local regulatory updates, guidelines and new regulations, and its implementation
• Establishes relationships with local medical device industry groups and works independently or with industry peers for advocacies to the Competent Authorities in matters of regulatory issues and to influence local policies.
• To actively liaise with regional/ global partners pertaining to regulatory affairs and providing support in the development of regulatory strategies and plans.
• Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy.
• Support internal audit or any external audit as necessary
• Support process of Advertising notification/submission
• Supports any other relevant activities or as assigned

Job requirements:

• Pharmacy or Science or Medical technology education or others
• Good communication skills in English and Thai (reading, writing, listening and speaking)
• Excellent interpersonal skills to handle sensitive and confidential information/situations
• Knowledge of MS Excel, Word, PowerPoint, VLOOKUP
• Good organization skills
• Having at least 1-2 years’ experience in medical device submission (CSDT submission) will be an advantage