- Charles River Laboratories (Wayne, PA)
- …responsibilities. ⦁ Assume a lead role in the development and presentation of regulatory training for Quality Assurance and operations staff. ⦁ Manage ... and Compliance projects and programs. ⦁ Participate in Corporate Quality Meetings, Regulatory Affairs and Compliance meetings,...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Jabil (West Chester, PA)
- …This person will also be responsible for the absence of significant quality systems issues and regulatory compliance actions by government agencies. ... foster vibrant and diverse communities around the globe. Are you experienced in Regulatory Compliance? Jabil is seeking a qualified Regulatory Compliance Manager… more
- West Pharmaceutical Services (Exton, PA)
- …and Technical Documentation for CE Marking. The Senior Specialist ensures timely and high- quality execution of all regulatory deliverables. In addition, the Sr. ... Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience + Experience with US FDA ...detail with planning, time management and organizational skills + Regulatory compliance competency including Quality Systems +… more
- Merck (Philadelphia, PA)
- …the identification, planning, execution, and management of activities that deliver high quality and timely regulatory and safety submissions for approval. The ... Director, Portfolio & Program Management (PPM)** The Associate Director in Regulatory Planning and Publishing works closely with various stakeholders to drive… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
- Merck (West Point, PA)
- …tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our West ... leader accountable for the quality oversight and management of the Quality team overseeing Regulatory Inspections, Site Internal Audit and Health Authority… more
- PCI Pharma Services (Philadelphia, PA)
- …regulated environment + Demonstrated expertise in quality management systems and regulatory requirements ( FDA , ISO 13485, Medical Device Directive) + Strong ... Quality Management System (eQMS) to ensure compliance with regulatory requirements and industry standards. This role leads the implementation, administration,… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …investigation and Regulatory Affairs for arranging more information/ samples from FDA . + Managing Quality Management Review meetings, circulating minutes of ... Quality Compliance Manager Department: Quality Location:...or more GXPs, in-depth knowledge of EU and US FDA regulatory standards, knowledge of regulatory… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …capture improvement opportunities including non-product softwareEssential Functions + Performs internal quality audits and effectiveness reviews ( FDA 's QSR, ISO ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- CSL Plasma (Philadelphia, PA)
- …Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with ... This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and… more