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The Sr. Director, Medical Safety will lead the development and implementation of a robust Medical Safety Program across GRAIL. This role will help shape, and implement the safety strategy and safety risk management for all GRAIL products during the product development and post-market surveillance phases.
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Experience in designing and generating clinical documentation required per EU Medical Device Regulation, including authoring Clinical Evaluation Plans and Reports, Post Market Clinical Follow-up and driving clinical input to Post Market Surveillance Plans and Reports.
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Assist with post market surveillance. Investigate complaints from on market products. Assist with post market surveillance. Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
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O Post-Market Surveillance plans and reports. o Post-Market Surveillance plans and reports. Experience working on the paper side of document control using electronic doc system, approving and routing documents.
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Review and manage post-market surveillance data and files, including tracking product-related Non-Conformance (NC) and CAPA status. This client is in the Orange County area, and their senior leadership team is seeking a Senior Manager of Quality Engineering to join their team.
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Supporting regulatory submissions by providing Post Market Surveillance data trends. The position of Product Surveillance Specialist will support the reporting obligations and management of communication between the manfacturer, importers and regulatory authorities for all medical device complaint activities.
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Manages processes and teams associated with control of nonconforming products, CAPAs, deviations, complaints management, complaint investigations, post-market surveillance, audits, quality system, document control, incoming inspections, product release, and other Quality Assurance related processes and teams.
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Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
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Post-Market Surveillance plans and reports. Post-Market Surveillance plans and reports. Organization : Typically reports to a Manager role or Project Manager role (for a defined period of time) based on organizational set-up, will have a lead person for day-to-day guidance.
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This position is an exciting opportunity to lead safety-focused real-world data studies to support the generation of clinical evidence for post-market clinical follow-up activities to meet regulatory requirements, patient safety, and post-market surveillance.
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You will assist the Clinical Study Manager (CSM) with administrative aspects of clinical studies including Investigational Device Exemption (IDE), post-approval, post-market surveillance, feasibility and/or marketing studies.
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This high-impact role will make direct contributions to highly visible projects such as new product introductions, obtaining market access for a specific product, continuous post-market surveillance, and pilots of emerging engineering technologies that are candidates for integration into current workflows.
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Participate as a Business Process Expert with the development and implementation of the post-market surveillance components in the Philips QMS.Participate with the rest of SRC Quality Leadership Team in providing an effective and efficient Sleep & Respiratory Care QMS.This Hybrid role may require travel up to 10.
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Collaborate with Post-Market Surveillance team to establish a robust process for overseeing the management of all post-market sustaining activities required to maintain global market access.
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Provide regulatory review for reporting activities required by EU MDR (i.e. post-market surveillance, reporting, etc. With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
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