Regulatory Affairs Manager

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