- PCI Pharma Services (Philadelphia, PA)
- …in quality management systems and regulatory requirements (FDA, ISO 13485, Medical Device Directive) + Strong knowledge of cGMP and other applicable ... requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards and regulations… more
- Evolent (Harrisburg, PA)
- …cases (eg, cardiac catheterizations, coronary interventions, endovascular procedures, implantable cardiac devices , etc) that do not initially meet medical ... calls) with requesting physicians or ordering providers, when available, within the regulatory timeframe of the request. + Utilizes medical /clinical review… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally...as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …control). + Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience ( Medical Device preferred to Pharma) OR ... well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care...Progressive leadership experience in the health care setting. + Medical Safety ( Medical Device preferred… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …with knowledge of 93/42/EEC Medical Devices Directive, SOR 98/282 Canadian Medical Device Regulations, ISO 13485, and any other medical device ... + Bioengineering, Mechanical Engineering, etc. with relevant educational experience for medical device industry preferred. Evidence of continued learning efforts… more
- Philips (Reedsville, PA)
- …European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282)- **_Desired_** + ... of 7+ years' experience in Quality within highly regulated product environments ( Medical Device , Automotive, Aerospace), with a focus on Supplier Quality,… more
- Guthrie (Sayre, PA)
- …care. Collaborates with providers in the provision of optimal implantable cardiac device management that follows all regulatory agency guidelines. Coordinates ... device interaction through biomedical and psychosocial interventions. The Cardiac Device Nurse (RN) in the Arrhythmia Center are independently accountable for… more
- Edwards Lifesciences (Philadelphia, PA)
- …**_Note: this Clinical Specialist will support field cases for PASCAL (mitral valve device ) in the local region, along coverage where needed across the US_** **_. ... ideal._** **How you will make an impact:** + Educate physicians on device handling, implantation and troubleshooting techniques related to the equipment required for… more
- Teleflex (Wayne, PA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... Medical Director, Interventional Urology and Urology Care (REMOTE)...dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of… more
- Guidehouse (Philadelphia, PA)
- …in your DNA? Breakthroughs in pharma are helping people live healthier lives, while medical devices enable patients to proactively maintain health - this is ... Life Sciences practice is an engine of innovation, helping pharmaceutical, biotech, medical device , and diagnostic companies develop custom solutions that tackle… more