- University of Pennsylvania (Philadelphia, PA)
- …of study activities, including subject recruitment, data collection, regulatory documentation, and communication with internal and external collaborators. ... of research protocols. Attention to patient safety, data integrity, and regulatory compliance is essential. This position requires adherence to University of… more
- Penn Medicine (Philadelphia, PA)
- …self and assigned area(s) are compliant with all applicable federal, state, and local regulatory standards (ex OSHA, TJC, DOH, FDA , HIPAA, etc.) + Oversees the ... Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA,...and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) Flexible and… more
- J&J Family of Companies (Spring House, PA)
- …and Translational Safety (PSTS) organization, will prepare and review regulatory submission documents that summarize toxicology, safety pharmacology, drug ... pharmacokinetic (PK) and discovery biology project leads, medical writers, global regulatory dossier leaders, and other subject matter experts (SMEs) to drive… more
- Sanofi Group (Swiftwater, PA)
- …are distributed throughout the world. This position guarantees the Quality and Regulatory compliance of products developed, manufactured and distributed by the site ... in accordance with Regulatory requirements and Global Quality policies and standards. This...practical expertise with cGMP requirements including WHO, ICH, US FDA , Canadian BGTD, Australian TGA, EU GMP, Japanese ;… more
- Norstella (Harrisburg, PA)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... therapeutic research and industry trend analysis, including competitive positioning, regulatory changes, domain-specific insights, and opportunities + Drive innovation… more
- Philips (Reedsville, PA)
- …of 10+ years' experience in Design Quality Engineering /Risk management for FDA regulated Medical Device (21 CFR 820, ISO 13485/14971) New Product ... Quality Engineering teams. + You have extensive experience engaging with FDA investigators, other external regulators/auditors during inspections/audits and able to… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …GxP compliance, Ethics & Compliance, and Pharmacovigilance, ensuring alignment with regulatory requirements and business objectives. This strategic leader will be ... engaging training ecosystem that enhances employee learning experiences and supports regulatory compliance. + Oversee the development and global deployment of… more
- University of Pennsylvania (Philadelphia, PA)
- …requirements; scheduling and conducting research visits in clinic; maintaining regulatory files; and preparing submissions to the Penn Biomedical Institutional ... collaborative research environment alongside a team of study coordinators, a regulatory specialist, project managers, investigators, and clinical staff to advance… more
- Teleflex (Wyomissing, PA)
- …Experience with documentation, method optimization, and cross-functional collaboration. * Familiarity with regulatory and quality frameworks (eg, FDA 21 CFR Part ... with minimal supervision. The Scientist contributes to project deliverables, supports regulatory and design control activities, and provides technical expertise to… more
- Oracle (Harrisburg, PA)
- …with engineering and compliance teams to ensure process efficiency, regulatory alignment, and continuous improvement throughout the software development lifecycle ... We are looking for someone with demonstrated awareness of regulatory standards and hands-on experience integrating regulatory ...of healthcare regulations and standards relevant to software (eg FDA 21 CFR Part 820, ISO 13485:2016, EU MDR)… more