- Jabil (West Chester, PA)
- …globe. Are you experienced in Regulatory Compliance ? Jabil is seeking a qualified Regulatory Compliance Manager to work in West Chester, PA. As the ... Regulatory Compliance Manager , you will...Regulatory Compliance Manager , you will manage all ...audits: eg Notified Body, Ministry of Health country inspections, FDA , J&J Corporate Audits for site. + Audit preparation… 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 of, and leads/executes regulatory strategy and tactical decisions… more
- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine ... as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- University of Pennsylvania (Philadelphia, PA)
- …participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory Affairs ... Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory … more
- J&J Family of Companies (Horsham, PA)
- …of America **Job Description:** We are searching for the best talent for a **Senior Manager , Health Care Compliance Officer** to be based in Horsham, PA. Our ... step of the way. Learn more at https://www.jnj.com/innovative-medicine. **Purpose:** The Senior Manager , Health Care Compliance Officer will be responsible for… more
- PCI Pharma Services (Philadelphia, PA)
- …+ Foster a culture of quality awareness, continuous improvement, and regulatory compliance **Qualifications:** The requirements listed below are representative ... overseeing and maintaining the Electronic Quality Management System (eQMS) to ensure compliance with regulatory requirements and industry standards. This role… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …+ Build and deliver training content for IT Systems used by Quality and Regulatory . + Analyze Quality and Compliance processes, translate Quality and ... Office **Job Description** **Discover Impactful Work:** The Digital Quality Systems Manager is responsible for ensuring efficient operation, support, and continuous… more
- Philips (New Kensington, PA)
- … and swift resolution of issues to uphold product safety and regulatory compliance , fostering transparency and cooperation in the resolution process. ... The Senior Manager -Corrections & Removals (C&R) will manage a team...enhancing the efficiency/effectiveness of C&R processes and maintains strict compliance with regulatory requirements governing product corrections… more
- United Therapeutics (Harrisburg, PA)
- …communications and/or commercial functions with a Master's Degree + Knowledge of compliance and regulatory framework + Exceptional soft skills including empathy ... communications, and/or commercial functions with a Master's Degree + Knowledge of compliance and regulatory framework + Exceptional soft skills including empathy… more