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无工作经验 -
招3人 -
11-09 发布
职位描述
职位描述： Job Responsibility:?1. Regulatory Planninga) Regulatory Strategy DevelopmentDevelopment of the Implementation Plan to align with the business need.b) Process Managementi) Handling the homologation (registration) of all products independently.ii）Ensure Quality Management System (QMS) is effectively established. Rresponsible for internal and external audit and provide regulatory consultant, identify and monitor compliance of business operationiii) As the project manager during the registration stage, make the strategic and competitive plans for the regulatory process, lead the whole project team to approach the key milestones according to the plan and manage the communication and escalation pathway in a consistent manner.iv) Coordinates the process with other functional members of the affiliate and HQ to ensure timely availability of required documents and samples, if appropriate.?2. Submission and Approvals of New Products and Marketed Products Maintenancea), Manage all the activities including but not limited to prepare dossier, obtain the regulatory approval and support the bidding efficiently and timely.b), Take appropriate actions to maintain all local marketed products in compliance with local and corporate regulatory requirements including manufacturing or labelling (insert and packaging) variations, renewals, repackaging and deregistration.?3. Regulatory ComplianceBe proactive to identify potential compliance issues and take corrective actions plans.?4. Lead the team and coach the subordinates?5. Manage the Regulatory Customer Relations and aware of any Regulatory Environment Change.?6. Proactively communicate with the business functions of the global regulatory status of new products and local regulatory trends that may impact the business.?7. Other duties assigned by Managing Director. 职能类别： 医疗器械注册
联系方式
苏州
公司信息
苏州高级人才咨询有限公司。
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