- Plan and perform clinical evaluations, Post Market Clinical Follow up (PMCF), support in creation of Product Safety Update Reports (PSUR), literature searches and clinical review of complaints for all devices in BrainCool AB.- Involving in strategic and operational clinical study management of the 950-patient and 400-patient pre-market and PMCF studies at +20 sites in the European Union to evaluate the safety and effectiveness/performance of RhinoChill on sudden cardiac arrest and stroke patients.Skills: ISO 14155 · Medical Device Regulation (MDR) · MEDDEV 2.7/1 Rev. 4 · Clinical Evaluation Report (CER) · Technical Documentation · Medical Writing · Grant Writing

- Managing the development of RhinoChill IntraNasal Cooling system (Class IIa and IIb) in compliance with MDR.Skills: Project Management · ISO 13485 · ISO 14971 · Risk Management · Technical Documentation · Product Development . Product Lifecycle Management · PMS Documents · FDA (De Novo and 510(k))

- Providing project management services encompassing R&D, regulatory submission to the FDA and technical documentation provision.

Skills: R&D · Verification and Validation (V&V) · Medical Devices · Product Development

Skills: Teaching · LabVIEW · MATLAB · Scientific Presentation · Scientific Writing · ANSYS