Provide QA & QC requirements for IT & OT systems Provide guidance / expertise on GxP risk-assessment at system level, functionality level, and data element level Provide guidance / expertise on EU MDR as well as 21 CFR 820 & 21 CFR Part 11 ...
Define and manage the roadmap for platform services, including data pipelines, reporting engines, interoperability modules, and shared integration frameworks. Establish requirements for scalable, secure, and globally compliant platform capa...
Lead early-phase product discovery, taking ideas from 0 to 1 and setting a bold vision for next-generation bio-sensing platforms. Identify and size market opportunities, using customer, competitive, and commercial insights to guide prioriti...
compliance with Dexcom standards Below skill are not mandatory but would be preferred Fusion Manufacturing knowledge Good...
/Omnipod) preferred. Experience with continuous glucose monitoring (CGM) technologies (Dexcom, Freestyle Libre, Medtronic...