- Penn Medicine (Woodbury Heights, NJ)
- …expiration dates; removes outdated items. + Other / Regulatory: + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, ... DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) + Flexible and readily adopts new processes and engages in practice operation changes. + Performs duties in… more
- Penn Medicine (Woodbury Heights, NJ)
- …generates front-end process reports as requested. Other / Regulatory: + Ensures compliance with all applicable federal, state, and local regulatory standards (ex ... TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) + Flexible and readily adopts new processes and engages in practice operation changes. **Credentials:** +… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …that a structured design and development process is followed, ensuring compliance with quality management systems and regulatory requirements, where applicable. + ... + Experience in medical device industries required, including experience in FDA or other regulated environments required. + Exceptional analytical, critical thinking… more
- Sokol Materials & Services (Skillman, NJ)
- …including risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: + ... test protocols, summary reports, and traceability matrices, ensuring regulatory compliance and accuracy. * Investigate and resolve deviations encountered during… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... medical or sincerely held religious belief or other legally required exemption._ _In compliance with the ADA Amendments Act, should you have a disability that… more
- BioLife Plasma Services (Trenton, NJ)
- …develop the skills to meet production and cost goals while ensuring compliance with regulations and BioLife SOPs. + **Travel Opportunities:** Through our ... QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment **We Offer Comprehensive… more
- Integra LifeSciences (Plainsboro, NJ)
- …in-process and final test sequencing. + Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable ... + Change control, non-conformance and CAPA support. + Participate in FDA inspections, ISO certifications, surveillance audits and customer audits. **QUALIFICATIONS**… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support, ... operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles and CPV.… more
- Benco Dental (Edison, NJ)
- …advanced forecasting, pricing optimization, and operational insights. + Cybersecurity & Compliance - Own the enterprise security posture, ensuring adherence to all ... + Familiarity with relevant regulations affecting healthcare-related supply chains (HIPAA, PCI-DSS, FDA UDI, or similar). + Strong financial acumen and the ability… more
- Terumo Medical Corporation (Somerset, NJ)
- …+ Demonstrate a commitment to patient safety and product quality by maintaining compliance with all TMC Quality Systems requirements. This includes but is not ... new product development and clinical activities. Fully adhere to all applicable FDA regulations, international guidelines and Terumo's policies at all times. +… more