Sr. Regulatory Affairs Specialist

Location: Singapore, Singapore City
Posted On: 6/15/2017
Job Code: Sr. Regulatory Affai
Job Description
• Responsible for development and implementation of Regulatory Affairs information systems and tools to establish metrics, determine trends, capacity planning and other insights that will enable MD Regulatory Affairs to accelerate and maximize the success of obtaining product registrations and supporting the lifecycle management of MD products from across multiple business units globally.
• Ensures RA systems, document/data management platforms and tools are effectively deployed.
• Uses these systems and tools for the compilation of regulatory information such as submission planning and tracking, country requests, portfolio and workload capacity planning.
• Implements standards and technical requirements for reliable, complete, efficient and secure data collection and storage globally.
• Leads and participates in influencing continual improvement of these IT systems, tools and platforms.
• Reviews process change recommendations and assists in implementing new procedures and documentation.
• Recommends, tracks and reports performance metrics as developed and defined.
• Assists in training on regulatory data management processes and platforms.
• Facilitates discussion and review across APAC groups within regulatory Affairs related to risk management, performance management, capacity planning and continuous improvement.
Category:Non-IT  code:new
Job Requirements
• Broad understanding of regulatory affairs and medical device regulations.
• Familiarity with current Regulatory Affairs tracking platforms (e.g. TrackWise, SharePoint, Excel).

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