Job DescriptionThe Analyst Global Post Market Surveillance (PMS) Compliance works with the Manager Global PMS Compliance, global PMS leadership, and cross-functional teams to ensure corporate/regional alignment and regulatory compliance.
Primary responsibilities will include continuous monitoring of the global post market surveillance regulatory landscape, and collaboration with global post market teams to implement proactive procedure/process/system improvements to ensure compliance.
In addition, this role will perform project management for PMS projects and CAPAs relevant to global compliance, ensuring the product vision, priorities, and solutions are actively serving functional and cross-functional business needs. This role will take responsibility for the delivery of the project deadlines and commitments.
Roles and Responsibilities: Support management to ensure on-going compliance of Intuitive to global PMS requirements, and alignment of internal corporate/regional PMS teams.Continuously evaluate Intuitive PMS against any new, emerging, or updated global PMS regulatory requirements, and proactively support implementation of procedure, process, system changes and training to address.Participate in internal/external audits as necessary; provide PMS SME expertise in the front and back room when needed.Author and manage global PMS regulatory responses as needed and ensure Intuitive RAQA and cross-functional alignment.Lead and organize project teams to drive focused results and projects/CAPAs related to global PMS compliance.Accomplish project objectives by planning and evaluating project related activities and communicating status to management on a regular basis.Prepare and complete action plans to implement productivity, quality, problem resolving, identifying trends, determine system improvements, and implement change.Perform other duties as directed.
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