- 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
- Insight Global (Philadelphia, PA)
- …including acquisition, installation, preventive maintenance, and decommissioning. - Ensure compliance with regulatory standards (eg, FDA , Joint Commission, ... systems, including diagnostic, therapeutic, and life-support equipment. -Expertise in regulatory compliance (eg, FDA , Joint Commission, NFPA, CMS). -Proficiency… 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
- Aerotek (Bethlehem, PA)
- …Attention to detail is crucial, as you will be working with FDA -regulated products, ensuring compliance with GMP/SOP standards. **Responsibilities** + Operate ... a Stand Up forklift for loading and unloading trucks. + Pick and store full pallets safely and efficiently. + Ensure quality standards are met over quantity. + Identify and correct mistakes to maintain product integrity. + Follow GMP/SOP guidelines diligently.… more
- Teleflex (Wayne, PA)
- …needs with available internal resources. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian ... Medical Device Regulations, and all other international regulatory requirements with which NeoTract complies. TRAVEL REQUIRED: 35-50% (Variable) The pay range for this position at commencement of employment is expected to be between $315,000- $340,000 however,… more