Consultant | Medical Devices | QARA United States & Europe Regulatory Manager – Point-of-Care Diagnostics I’m partnered with a fast-growing medical diagnostics startup developing point-of-care technology that provides rapid insight into a patient’s coagulation status. Their platform is already progressing in the EU and gaining strong clinical traction. They’re now looking for a hands‑on Regulatory Manager to drive EU regulatory strategy and submissions as they scale. The Role Lead and support regulatory activities with strong focus on EU CE/IVDR submissions . Prepare, coordinate, and maintain technical documentation for CE/IVDR. Integrate regulatory requirements across the product lifecycle (hardware, consumables & software). Act as point of contact with Notified Bodies; support audits, Q&A, and remediation. Partner with Quality, Engineering, and R&D on documentation, risk management, and compliance. The Profile 5–8+ years’ Regulatory Affairs experience in medical devices or diagnostics. Proven experience working on CE/IVDR submissions . Strong familiarity with ISO 13485, ISO 14971, IEC 62304, and EU regulatory frameworks . Comfortable in a startup environment, hands‑on, adaptable, and collaborative. Why This Role Shape regulatory strategy in a scaling, high‑impact environment. Work on technology with meaningful clinical application in emergency and critical care. Highly cross‑functional role with broad ownership and visibility. #J-18808-Ljbffr
A leading IT staffing company in California is looking for an experienced Accessibility Tester. The ideal candidate will have expertise in accessibility testing for blind and low-vision individuals, including knowledge of relevant standards and testing tools. Responsibilities...
...research, to engage and inform viewers on the most essential news, issues, and events taking place in their communities. Beyond TV news distribution, our newsrooms publish via the Spectrum News app and connected television. We're committed to providing viewers with...
...Allworth Financial ( ) is an independent investment advisory firm providing full-context... ..., Allworth Financial is a high-growth, private equity-backed, multibranch registered investment... ...our Equity Purchase Program (Contract, intern, and part-time employees are not...
...Job Description Job Description This part-time position is responsible for the day-to-day tasks... ...a welcoming and meaningful experience to all library patrons, in a professional and courteous manner. The Library Assistant provides support to library customers while delivering...
...and interpersonal communication skills. WE WOULD REALLY LIKE IT IF (but its not a deal breaker) You have experience with C#, C++, or Python languages for PC application software. You have experience with VHDL. You have experience designing safety-critical...