- University of Pennsylvania (Philadelphia, PA)
- …oversight submissions for regulatory documentation through the IRB, CTSRMC, FDA and all applicable institutional regulatory review committees. In collaboration ... pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA , as well as organize and maintain all regulatory affairs documentation/files… more
- Covenant Health Inc. (Knoxville, TN)
- …from radiologists/physicians/surgeons, other health care professionals as well as ACR / FDA /other. Initiates and maintains Breast Center Program development . + ... or other accreditation as required or requested. Adhere to established FDA regulatory requirements. Maintain and document all required quality control measures… more
- United Therapeutics (Morrisville, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... essential services that streamline patient access to therapy. Compliantly adhering to FDA and other regulatory guidelines, the Patient Navigator takes ownership of… more
- The Honey Baked Ham Company, LLC (Alpharetta, GA)
- …and compliance. + Ensure HBH policies and programs are consistent with agencies such as FDA , FSIS and FDA Food Code. + Work cross functionally to support the ... experience preferred + USDA experience preferred + HACCP/GFSI certification preferred + FDA Food Code experience preferred + Ability to influence others to deliver… more
- WuXi AppTec (Middletown, DE)
- …QC laboratories, workflows, and processes meet cGMP requirements and global regulatory standards ( FDA , EMA, ICH, USP, EP, JP). * Coordinate QC support for technology ... all QC activities are executed in compliance with cGMP, FDA , EMA, ICH, USP, EP, JP, and other applicable...site startup or major expansions. * Strong knowledge of FDA , EMA, and ICH guidelines and global regulatory expectations.… more
- Jabil (Hunt Valley, MD)
- …computer systems and process in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic fill-finish environment and ensuring the proper ... Validation (CSV) program and supervise CSV associates. Ensure compliance with cGMP, FDA , EMA (Annex 1), and other global regulatory requirements for validation and… more
- Community Health Systems (Key West, FL)
- …of breast diseases. This role requires advanced technical skills, adherence to FDA /MQSA, ACR, and state regulatory standards, and a strong commitment to patient ... ensuring readiness for procedures. + Establishes and maintains all documentation for FDA inspection to ensure compliance with MQSA regulations for the facility. +… more
- Globus Medical, Inc. (Audubon, PA)
- …Sterile Manufacturing Quality. This position ensures compliance with applicable regulatory requirements ( FDA QSR, ISO 13485, EU MDR, MDSAP, etc.) and alignment with ... is needed within Medical Device Quality Assurance/ Quality Systems with experience in FDA and CE Notified Body inspections + Experience in product quality assurance,… more
- Caris Life Sciences (Irving, TX)
- …are in accordance with internal SOPs, Quality System Requirements which include ISO 13485, FDA QSR, IVDR, SOX, SOC2, and IEC 62304 + Reviews and approves various ... and applicable Software Validation Planning documents in alignment with FDA QSR, 21 CFR Part 11, and GAMP5 regulation...of SDLC process and the application of ISO 13485, FDA QSR, 21 CFR Part 11, IEC 62304, GAMP5,… more
- Bayer (Indianola, PA)
- …to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls. The Software Engineer will be involved in all aspects of ... that meets regulatory standards and guidance such as : + FDA 21 CFR 820.30 - Design Controls; + FDA Cybersecurity in Medical Devices; + IEC 62304 - Software in… more