Boston Scientific Senior / Regulatory Affairs Specialist 

Singapore, Singapore 

995871052

Key Responsibilities

• Provides input on regulatory-related issues associated with compliance and achieving the business plan. Provide the management team with regular updates on product registrations status and/or timely escalation with proposed solution.
• Preparing, coordinating and submitting regulatory applications to the local health authority and agencies.
• Ensure product registrations are reviewed and renewed as required.
• Ensure product changes/ amendments are approved in timely manner and work with relevant stakeholders to minimize business disruption.
• 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 local health authority and agencies 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.
• Review and obtain approval, where necessary, for Promotional Materials.
• Supports any other relevant activities or as assigned.

Key Skills and Experiences

• Prior experience of minimum 3 to 5 years in Medical Device Regulatory Affairs
• Knowledge of GDPMD will be value added.
• Knowledge of regulatory submissions and requirements for other ASEAN countries will be value added.
• Solid oral and written communication skills (both English and Indonesian)
• Strong analytical and critical thinking
• Team player