- GE HealthCare (State College, PA)
- …work instructions, PFMEAs, control plans, and validation protocols. + Ensure compliance with regulatory standards (eg, ISO 13485, FDA QSR) and internal quality ... in an engineering or operations role. + Experience in an ISO13485, FDA regulated or Medical Device manufacturing environment + Strong understanding of ultrasound… more
- Globus Medical, Inc. (Eagleville, PA)
- …manufacture of high-quality products and to facilitate compliance with regulatory requirements. **Essential Functions** **:** + Overseas operations efficiency and ... compliance within company policies and procedures (eg, compliance with FDA , ISO 13485, or other regulations). + Complies with...+ Demonstrated knowledge of ISO and quality systems as FDA and OSHA requirements, as a plus + Experience… more
- Biomat USA, Inc. (Fairless Hills, PA)
- …activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a ... all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration… more
- Charles River Laboratories (Malvern, PA)
- …accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization. Utilizing this broad portfolio of products ... drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. At Cell Solutions,...the development of 100% of the current commercially available FDA -approved immunocellular therapies. Our mission is to provide a… more
- Stryker (Philadelphia, PA)
- …+ Lead and mentor teams to build robust software architecture aligned with regulatory requirements. + Drive development and utilization of tools and systems that ... management. + Knowledge of medical device regulations (eg, US FDA 21 CFR Part 820, ISO 13485, ISO 14971,...820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, FDA cybersecurity guidance). 115,600.00 to 245,800.00 salary plus bonus… more
- WellSpan Health (York, PA)
- …and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies. Ensures billing of study procedures to the appropriate funding ... consent documentation requirements are met as per the GCP, FDA and IRB guidelines. Registers and accomplishes randomization of...the safety and welfare of human subjects (ie, DHHS, FDA and IRB research regulations, HIPAA privacy and research… more
- Vitalief (Philadelphia, PA)
- …study visits, maintain databases, and ensure accurate data collection/entry. + Manage regulatory binders, IRB submissions, and compliance with FDA , IRB, and ... (academic/institutional site experience preferred). + Strong knowledge of GCP, FDA , and IRB regulations. + Experience in patient recruitment/retention, IRB… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized ... with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global...requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience… more
- Penn Medicine (Philadelphia, PA)
- …all areas of accountability are compliant with all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW, ... supervision and direction in regards to all administrative, financial, regulatory , quality, human resources, patient/employee satisfaction, and clinical aspects for… more
- Penn Medicine (Philadelphia, PA)
- …all areas of accountability are compliant with all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW, ... supervision and direction in regard to all administrative, financial, regulatory , quality, human resources, patient/employee satisfaction, and clinical aspects for… more