Sr. Manager, Regulatory Affairs - International - IRC9005

Details: TheSenior Manager, Regulatory Affairs will develop and implementregulatory strategies and guidance for Asia Pacific business based onInternational requirements as defined in FDA regulations, ISO 9001 Standards,ISO 13485:2003 Standard and other International Regulations. This individualwill combine knowledge of scientific, regulatory and business issues to enableproducts that are developed, manufactured or distributed to meet requiredlegislation. Responsible for managingand providing Regulatory strategy for Asia Pacific products. Manages the planning andfiling of documentation with all international regulatory agencies. Ensures that the teamobtains/generates information to be submitted to regulatory authorities andprepares required regulatory submissions according to the business strategy.. Acts as liaison withappropriate local, national and international regulatory authorities. Leads relevantregulatory project planning and review meetings; conducts the final documentreview and corrections. Identifies and ensuresthe establishment and monitoring schedules for submission documentation, reviewof documentation, protocols and reports received; prepares additional writtenmaterials needed. Ensures the teamprepares appropriate Files, DAL’s (Distributor Authorization Letters) and otherInternational Registrations proactively to protect our commercializationopportunities. Manages all documentpreparation and responses to distributors, governmental bodies, supplements,and amendments. Monitor the internationalregulatory environments, and provide executive management with assessments ofthe impact of new and changing regulations. Identifies and ensuresthe establishment and monitoring schedules for submission documentation, reviewof documentation, protocols and reports received; prepares additional writtenmaterials as needed Manages closely 3 rd parties Review productcomplaints for MDR reporting, Field Safety Corrective Action as required. Manage closely 3 rd party to support local registrations. Responsible for compliance with applicableCorporate and Divisional Policies and procedures Develop new regulatorypolicies, processes and SOPs and train key personnel on them
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