- Olympus Corporation of the Americas (Center Valley, PA)
- …clinical assessments as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these ... Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance . Performs routine assignments independently; supports and… more
- Guthrie (Sayre, PA)
- …teams. Operations & Compliance + Deep understanding of human-subjects research compliance (AAHRPP, FDA , IRB, GCP, ICH). + Experience in integrating clinical ... administrative executive to collaboratively lead the strategic, operational, and compliance functions of DGF. This role is central to...or pharmaceutical-sponsored research or regulatory fields such as the FDA , NIH, or HHS. + Minimum 5 years of… more
- PCI Pharma Services (Philadelphia, PA)
- …deviations, and complaints to identify patterns requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and ... and maintaining the Electronic Quality Management System (eQMS) to ensure compliance with regulatory requirements and industry standards. This role leads the… more
- Rise Baking Company (York, PA)
- …PPEs + Create, update, and audit sanitation program and all SSOPs to ensure compliance with FDA and GFSI requirements + Assist with updating quality systems ... Role) Job Purpose Lead the Sanitation team to achieve full plant compliance with sanitation/cleaning standards, food safety, and personnel safety, maintaining all… more
- Fotona (Philadelphia, PA)
- …United States, in accordance with Fotona-approved protocols and guidelines. + Strictly adhere to FDA clearances and compliance . + Successful completion of 6 to 8 ... trainings per month. + Act as a key point of contact for customers and colleagues on medical inquiries, product protocols, and clinical applications. + Contribute to creating a positive internal working environment and successful business relationships between… more
- Philips (New Kensington, PA)
- …issue resolution through robust tracking and reporting mechanisms. + Ensure regulatory compliance with FDA design controls and global standards; manage project ... Minimum of 8+ years of professional experience in product/solution development within FDA -regulated medical device or technology sectors. + Minimum of 8+ years… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …ensure compliance with pharmaceutical traceability and labeling standards + Maintain FDA and DEA regulatory compliance by ensuring cleanroom integrity and ... quality checks to ensure shipment integrity, proper labeling, and compliance . + Generate and verify shipping documentation such as...Time Management + Familiarity with DEA, DSCSA, and cGMP compliance + Experience with RF technology + Experience in… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …returns adhering to company policies, procedures, and documentation requirements + Maintain FDA and DEA regulatory compliance by ensuring cleanroom integrity and ... capacity with Excel and Outlook + Pharmaceutical Regulatory statues, GMP compliance + Previous Distribution, Inventory Control, and Forklift training + Working… more
- NTT DATA North America (Pittsburgh, PA)
- …working with healthcare, pharmaceutical, or biotech clients. Knowledge of GxP, HIPAA, FDA regulations, and other compliance frameworks in healthcare and life ... business outcomes by tracking KPIs and product success metrics. Ensure compliance with industry standards, regulations, and quality frameworks relevant to healthcare… more
- CTG (Myerstown, PA)
- …training in-person, virtually, and in hybrid environments. + Knowledge of regulatory compliance and FDA guidance for dissemination of medical information. ... **Experience:** + Proven experience in clinical, medical affairs, or related roles within radiology or medical science liaison functions. + Experience with advisory boards, speaker training, and investigator-initiated research. + Demonstrated ability to manage… more