The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This i

Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor

Utilization Review Tech III Facility Lower Bucks Hospital Location US PA Bristol ID 2024 160307 Category Business Professional Position Type Full Time Shift Days Job Type Non Exempt Overview Join an award winning team of dedicated professionals committed to our core values of quality, compassion and community! Lower Bucks Hospital , a member of Prime Healthcare, offers in

This person will be responsible for the performance optimization for a fixed number of assets to exceed budget requirements and to drive best in class performance. Activities include responding to known deficiencies, responding to current issues and proactively identifying and resolving performance gaps. Directly influences cost of up to $20 MM for the plants assigned. Th

The science of electronics is transforming exponentially through innovation and connectivity around the planet. Every day, breakthroughs are making technologies from micro processors, memory chips and flat panels to photovoltaic cells even smaller and more powerful, opening up countless new possibilities in how the world lives, works and connects. Air Liquide Advanced Mat

Functional lead experience in previous management of at least 2 SAP Commerce (formerly Hybris) e commerce implementations and a good understanding of SAP Commerce end to end solution implementations. Lead and manage the quality assurance process for SAP Commerce projects. Develop, document, and execute test plans and test cases to ensure the quality of SAP Commerce soluti

Join the mission of Improving Lives as a Safety Associate at Jefferson Health. With more than 42,000 employees, wersquo;re the second largest employer in Philadelphia and the largest health system in the Philadelphia region. And our work to improve lives is never done. Safety Associates are responsible for the following Transports patients to and from different areas acco

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title Quality Auditor (2nd shift) Location Philadelphi

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title Quality Auditor Location Philadelphia, PA Depart

What's the role? The Manufacturing Manager directs and oversees pre fabrication manufacturing workflow, as well as operational activities to include sequencing, staging, workforce planning and scheduling. This position leads and/or facilitates all efforts to strive towards on time deliver, customer with a focus on improving performance in the key areas of safety, efficien

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EnerSys is the global leader in stored energy solutions for industrial applications. We have over thirty manufacturing and assembly plants worldwide servicing over 10,000 customers in more than 100 countries. Worldwide headquarters are located in Reading, PA, USA with regional headquarters in Europe and Asia. We complement our extensive line of Motive Power and Energy Sys

The Compliance Manager works with the Director of Compliance and Chief Compliance Officer to support our Global business on compliance matters relating to adherence to relevant policies, codes, laws, and regulations impacting business operations. The Compliance Manager will assist with various aspects of our compliance program, including compliance training, auditing and

The Sr Quality Control Operator ensures agreed upon quality standards are met in final layouts for production assignments. With limited guidance from the client project team, this position executes digital and analogue techniques to confirm final product meets project standards and complies with technical specifications, copy content and regulatory requirements. This posi

This role will provide global leadership for process development and engineering design of new and existing chemical manufacturing processes. Scope includes driving creative engineering solutions to ensure that commercialized processes are robust and deliver products that exceed customer requirements, cultivating strategic relationships with external technology and servic