- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + ... cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver… more
- J&J Family of Companies (Spring House, PA)
- …: CRO Functional Management, Ethics Committees, Health Authorities including the FDA and other Regulatory bodies, Investigational Sites, and others. ... Commercial functionsacrosscareer,withexposuretoclinicaldevelopmentteams/process(from PhI-PhIV through filing) + Strong knowledge in regulatory and operations compliance and quality control experience +… more
- Wacker Chemical (Allentown, PA)
- …the QMS. + Regulatory & Documentation: + Ensure compliance with applicable regulatory requirements ( FDA , EU MDR, etc.). + Oversee document control systems ... for ensuring that all processes, documentation, and operations meet regulatory and quality requirements for medical device manufacturing and distribution.… more
- Merck (North Wales, PA)
- …questions for FDA edata mailboxes (CBER/CDER), attendance at meetings with regulatory agencies ( FDA , EMA, PMDA). + Guide project teams preparing submission ... and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... Integration, Customer Service, etc.). + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the… more
- Fujifilm (Harrisburg, PA)
- …systems. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... factors, which may include customer impact, HCUS business priorities, and regulatory requirements. Normally receives little instruction on day-to-day work and… more
- Fujifilm (Harrisburg, PA)
- …others. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... into actionable user stories and system requirements. + Integrate input from regulatory , marketing, and implementation teams to maintain compliance and accuracy in… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …CFR Part 803, 806, 820) + Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings ( FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs) + Corrective ... Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care Compliance. **Job Duties**… more