raakhee vijayaraghavan

I’m a seasoned life science professional with over 14 years of experience driving innovation in molecular diagnostics, companion diagnostics (CDx), and regulatory-aligned R&D. Most recently at Illumina, I led pharma-sponsored CDx programs from early feasibility through global launch, combining technical rigor with strategic foresight across cross-functional teams.

My expertise spans assay development, genomic technologies and quality systems compliance, with a strong foundation in regulatory submissions including FDA and IVDR pathways. I’m passionate about advancing precision medicine through thoughtful product development, risk management, and collaborative execution.

As a certified Biotechnology Project Manager and PMP candidate, I bring a balance of leadership and hands-on technical know-how. I’m committed to empowering teams, building thoughtful workflows, and contributing to biotech innovations that make a meaningful impact on patient care.

Seasoned biotechnology professional with 14+ years of experience leading innovation in molecular diagnostics, companion diagnostics (CDx), and regulatory-aligned R&D. Proven success driving assay development, product optimization, and cross-functional collaboration in IVD and oncology-focused programs. Knowledge and have experience in regulatory strategy and submission planning (FDA, IVDR), quality systems (ISO 13485), and risk documentation. Known for mentoring teams, advancing precision medicine, and managing complex programs from feasibility through global launch. Certified in Biotechnology Project Management and actively pursuing PMP certification. Passionate about integrating AI into biotech innovation and making a tangible impact on patient care through data-driven diagnostics.

I hold a Master's degree in Biotechnology and a Bachelor's degree in Biochemistry, providing a strong academic foundation in molecular biology, assay development, and scientific research. I’m certified in Biotechnology Project Management, equipped with skills in strategic planning, risk mitigation, and cross-functional execution across life science programs.

Currently, I am a PMP (Project Management Professional) candidate, further expanding my ability to lead complex projects in regulated environments. I’m also pursuing the Regulatory Affairs Certification for Medical Devices, strengthening my expertise in FDA submissions, IVDR compliance, and post-market strategies. In addition, I’m an active mentee in the San Diego Regulatory Affairs Network (SDRAN), continuously engaging with industry professionals to deepen my regulatory knowledge and leadership potential.