The Project Manager leads cross-functional new product development projects for IVD assays and diagnostic instruments from concept through launch. They are responsible for project planning, schedule management, risk mitigation, and ensuring compliance with FDA regulations.
Responsible for selling technical diagnostic products to laboratories via telephone to meet and exceed sales growth goals. The role involves identifying new business opportunities, managing existing accounts, and transitioning into a field representative role within 18-24 months.
Lead the Clinical Operations team by managing CRAs and overseeing clinical trial logistics and biospecimen acquisition. Ensure high-quality end-to-end management of clinical studies while maintaining compliance with regulatory standards.
Integrate cybersecurity requirements into the design and development of software for diagnostic platforms. Ensure compliance with FDA guidance and maintain secure design documentation throughout the product lifecycle.
Support regulatory and quality processes to ensure medical device design, development, and manufacture comply with applicable requirements. Manage product compliance throughout the lifecycle, including regulatory submissions, labeling, and adverse event reporting.
