- AbbVie (North Chicago, IL)
- …Technology Systems Engineering team to contribute to the development, launch, and maintenance of medical devices and drug / device combination products. As ... the accurate and compliant management of on-market Design History Files (DHFs) for medical devices and combination products within the scope of systems… more
- Abbott (Plymouth, MN)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... of our Plymouth MN location in the Structural Heart medical device division. Our business purpose is...production personnel in the manufacturing and testing of product devices + Recommend and implement process, tooling, equipment changes… more
- ICON Clinical Research (Blue Bell, PA)
- …we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With ... **Stakeholder Communication & Leadership** + Engage with global stakeholders including regulatory authorities, key opinion leaders (KOLs), client medical teams,… more
- IQVIA (Durham, NC)
- …in line with the requirements of the FDA (FDCA) / PhRMA / FTC for pharmaceuticals and medical devices on assets for clients. You will be expected to be part of ... research design, methods, and outcome measures. + Advanced knowledge of pharmaceutical and medical device guidelines and regulations. + Experience on an approval… 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
- Teleflex (Morrisville, NC)
- …* Additional experience in clinical setting, biostatistics, IDE clinical studies or medical device product support. * Demonstrate aptitude in and knowledge ... 50% **Requisition ID** :12656 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health… more
- Philips (Latham, NY)
- …14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), etc. + You ... experience in full-cycle, global Quality Program/Project management within FDA regulated medical device Manufacturing /Supply Chain environments, with a focus… more
- Abbott (Sylmar, CA)
- …applicable US and non-US Quality System Requirements and other relevant regulations for medical devices . Previous experience with regulatory body. Knowledge ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Medtronic (Northridge, CA)
- …and cross-functional teams to ensure compliance with ISO 10993 standards and global medical device regulations. The role also supports product development by ... concise, and well-structured test plans and reports to support regulatory submissions. This role involves coordinating required chemical characterization testing,… more
- GE HealthCare (Waukesha, WI)
- …responsibility for all systems engineering tasks for product throughout the medical device development phases associated with multi-generational new product ... problem definition, technical decomposition, and project estimation. + Familiarity with Medical Device Software Design Principals, requirements for meeting… more