and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR..., regulatory agency guidance documents) Review and approve R&D, quality, preclinical and clinical documentation for submission...
to work in an up-tempo R&D environment. Playing a key role on our project teams, you will work alongside a group of passionate... standards and practices (IEC 60601-1, ISO 13485, and other applicable standards) a plus Effective written and verbal...
with multiple ADC functions (RA, Ops, R&D, IT all levels up to and including division president). This leader is responsible.... Ability to influence decisions made by Operations, R&D, Commercial, and other disciplines to maintain customer satisfaction and division...
communicate with technical leadership. Contribute to the development of new and innovative solutions in a high-paced R... certified systems, especially experience with IEC 61508 - Experience handling and analyzing large data sets and with AWS...
designs across engineering disciplines, documenting risks and ensuring risk controls and requirements are met. Ensures R.... Designs to meet regulatory requirements as determined by FDA, ISO, and IEC standards. What You'll Bring B.S. or M...
and ISO/IEC standards, including ISO 13485, IEC62304, and ISO 14971. Understanding of cybersecurity techniques such as code... to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every...
until the position is filled. We are looking for an exceptional compliance leader to join our R&D team in North America... and sustaining offers with proper interpretation. Interface and collaborate with Global R&D engineering teams providing necessary...
. Troubleshoot complex automation and safety issues. Document and present R&D activities. Collaborate with engineers, scientists... with control hardware and writing design specifications. Familiarity with functional safety standards (e.g., IEC 61508, IEC61511...
(R&E) Business Operations Office. Administrative support shall utilize Microsoft (MS) Office to include MS PowerPoint, MS... maintenance of the R&E manpower roster, phone rosters and space allocations. Capture and maintain R&E physical space to ensure R...
, procedures, and housekeeping standards. Interface with cross functional groups including R&D, Program Management, Operations... such as ISO13485 and FDA QSR's. Advanced skills in MS Office, software defect tracking tools preferred. Understanding of IEC 62304...