Collaborate closely with marketing, engineering, quality, regulatory, clinical, and product development teams to ensure compliance with relevant medical device standards (e.g., ISO 13485, IEC 62304, MDR, FDA 21 CFR Part 820). Are you an experienced Software Project Manager with a background in the Medical Device industry? * Hold a Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or related field. * Have proven project management experience in software development in the medical device or healthcare technology industry, or other regulated industry. * Have proven track record working with medical device regulations (EU MDR, FDA), quality systems (ISO 13485), and software lifecycle standards (IEC 62304). * Are familiar with Software as a Medical Device (SaMD) and/or AI-based software projects from concept to commercialization.
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