Regulatory Affairs Specialist

We  are seeking a Regulatory Affairs Specialist for our Indonesia Team. He/she ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.  He/she Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation and provides management team with regular updates on product registration and new regulations from government body.

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 registration and/or timely escalation with proposed solution.
• Preparing, co-ordinating and submitting regulatory applications to the local health authority.
• 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, SDPPI, 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
• 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 5 years in Medical Device Regulatory Affairs
• Knowledge of GDPMD will be value added
• Solid oral and written communication skills (both English and Indonesian)
• Strong analytical and critical thinking
• Team player

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