Working with department management provides global regulatory strategies and regulatory plans
Working with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities
Coordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements
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Work closely with cross-functional teams (Legal, Finance, Operations, and Project Delivery) to align commercial terms with business strategy and project requirements.
Support risk management efforts by identifying potential commercial and contractual risks and ensuring appropriate mitigation measures are in place.
Monitor project progress, deliverables, billing milestones, and payment terms using internal systems.
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Own high-priority incidents, troubleshoot cross-module integrations, and support processes spanning sales, materials management, billing, stock movement, and business-critical system interactions.
Continuous Improvement
Go beyond firefighting. Lead root cause analysis, contribute to system enhancements, support upgrades and testing activities, and identify opportunities to improve operational efficiency and system stability.
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Work closely with cross-functional teams (Legal, Finance, Operations, and Project Delivery) to align commercial terms with business strategy and project requirements.
Support risk management efforts by identifying potential commercial and contractual risks and ensuring appropriate mitigation measures are in place.
Monitor project progress, deliverables, billing milestones, and payment terms using internal systems.
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Work closely with product specialists, service, marketing and sales team to prepare application notes, technical reports, and case studies highlighting best practices and successful implementation.
Responsible for managing the overall operations and development of the Regional Testing and Training laboratory in the Asia Pacific Technical Centre.
Plan the implementation and facilitation of activities and events, material production and distribution, and other resources to ensure that operations are managed effectively.
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Troubleshoot operational bottlenecks and provide real-time updates to regional management.
Communicate with 3PL (third-party logistics) providers, couriers, freight forwarders, and warehouse partners in Malaysia to ensure timely dispatch and delivery.
Analyze compensation trends and provide recommendations to management on reward-related matters.
Administer employee benefits programs, including medical insurance, wellness initiatives, leave benefits, retirement schemes, and other employee offerings.
Coordinate with insurance brokers, benefit providers, and external vendors to ensure smooth delivery of benefit programs.
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Analyze compensation trends and provide recommendations to management on reward-related matters.
Administer employee benefits programs, including medical insurance, wellness initiatives, leave benefits, retirement schemes, and other employee offerings.
Coordinate with insurance brokers, benefit providers, and external vendors to ensure smooth delivery of benefit programs.
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