- Jabil (West Chester, PA)
- …will support key quality systems, ensure compliance with internal and regulatory standards, and provide day-to-day engineering support to manufacturing operations. ... TIC, MIC, QIC). + Engage in internal/external audits and regulatory compliance activities. + Provide training and guidance to...Quality Engineering (eg, CQE) is a plus. Benefits + Medical , Dental, Prescription Drug, and Vision Insurance with HRA… more
- St. Luke's University Health Network (Easton, PA)
- …intra cavity devices + Perform proper disinfection, as per equipment and regulatory standards of all medical equipment/ devices + Records diagnostic ... of a patient's ability to pay for health care. The Diagnostic Medical Sonographer performs ultrasound patient examinations on obstetric patients under the directions… more
- Teleflex (Wayne, PA)
- …years in a clinical project management role in the Clinical Research Department of a Medical Devices / Pharmaceutical company / CRO. * Experience in the field of ... functional budget. * Ensure the team works with the Regulatory lead and Medical Director to create...14155 and 13485, experience with Class II & III medical devices preferred, documented basic - continuing… more
- Edwards Lifesciences (Philadelphia, PA)
- …+ Knowledge and understanding of cardiovascular science + Moderate understanding of medical device regulatory requirements and documents, device ... (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) or related medical device , clinical, or Certification in RDCS (Registered Diagnostic… more
- Merck (North Wales, PA)
- …cross-functional impact, including drug device /combination products and software as medical device platforms. Reviews and resolves issues that span diverse ... Building, Human Resource Management, Immunoassays, Immunology, Immunotherapy, Management Process, Medical Devices , Mentoring Staff, Ophthalmology, Pathophysiology, People… more
- Globus Medical, Inc. (Audubon, PA)
- …work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + ... At Globus Medical , we move with a sense of urgency...changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems.… more
- Globus Medical, Inc. (Audubon, PA)
- …work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + ... At Globus Medical , we move with a sense of urgency...as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for… more
- Cardinal Health (Harrisburg, PA)
- …regulation) preferred * Experience in private practice strongly preferred * Familiarly with medical device and pharmaceutical regulation * Active license in good ... **_What Regulatory contributes to Cardinal Health_** Legal provides the...regulations; and other product-specific environmental / sustainability drug and device lifecycle obligations and stewardship programs. This role will… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides ... submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
- Jabil (West Chester, PA)
- …preferred. + At least five (5) years of experience in the QSR/ISO-regulated medical device operation, including 2-3 years specific experience in a ... diverse communities around the globe. Are you experienced in Regulatory Compliance? Jabil is seeking a qualified Regulatory...exempt personnel + Knowledge of the US and international medical device quality system regulations, standards and… more