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Regulatory Affairs Program Manager III Location US-WA-Bothell ID 2024-1337 Category Quality Assurance/Regulatory Affairs Position Type Full-Time Work Model Hybrid Company Overview Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company's BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com. Overview Verathon is looking for a Regulatory Affairs Program Manager III to become the newest member of our QA/RA Team located in Bothell, WA. The Regulatory Affairs Program Manager III is responsible for supporting the RA department in Bothell and in Burnaby, BC in the preparation and organization of documents supporting compliance to medical device industry regulations and corporate quality policy. The person in this position will be responsible for establishing and maintaining regulatory, clinical, and regulatory legal files (both paper and electronic for ease of access by department personnel and world-wide government agencies and in compliance with applicable medical device world-wide regulations. This person will assist in the assembly, review and record archival for all regulatory submission to the various FDA, HC, EU and rest of world (ROW) government agencies. Responsibilities * Follow all policies, procedures, and standards for controlled documentation to ensure compliance with corporate document management policy * Responsible for the administration of the Regulatory Affairs Management Software tool * Provide cross-functional teams with product registration information to support global market launches, compliant distribution controls, and accountability of product registrations * Coordinate and track product registration programs and projects and provide periodic status updates to management * Work closely with Business Unit Leaders, Global Sales and Product Marketing to ensure NPD launch planning, and Global registration renewal are in alignment with business priorities * Serve as Regulatory Liaison with FDA to obtain Certificates of Foreign Government, and Certificates of Free Sale. * Serve as Regulatory Liaison with external vendors to obtain Apostilles and legalization of documents necessary for international submissions * Monitor distributor contracts. Manage and track letters of authorization and pipeline products assigned to distribution partners * Tracking of RA expenditures as it related to regulatory submission fees, an associated vendor * Effectively communicate project plans, changes, and issues on a periodic basis that have direct impact on product launch scheduling and renewal timelines * Work closely with Regulatory Associates and Verathon distributors to ensure new product registration, renewals, and product changes are processed timeline and executed compliantly * Coordinate regulatory and clinical documents management and maintenance to assure clear traceability and integrity of regulatory documentation as required by applicable regulations * Maintains a broad awareness of the roles of immediate team members and cross-functional teams * Support the assembly, and review all regulatory submissions to the vario