Director, Quality Assurance and Regulatory Affairs
A highly accomplished and certified Quality Assurance, Regulatory Affairs, and Clinical professional with over 22 years of dedicated experience in the life sciences industry. Raje excels in implementing, standardizing, and certifying robust Medical Device Quality Management Systems (QMS), including expertise in ISO 13485, MDSAP, and FDA QSR compliance. With a proven track record of developing and ...
Experience: 23+ years
Submissions: 50 510(k), 10 De Novo, 5 PMA
Raje Devanathan provides regulatory consulting services to clients in:
Holds a strong academic foundation with a Post-Graduate Certificate in Global Regulatory Affairs from Humber College, complementing a Master of Science in Molecular Biology & Biochemistry and a Bachelor of Science in Molecular Biology & Genetics. This robust educational background provides a deep understanding of scientific principles essential for navigating complex regulatory landscapes in the life sciences industry. Their interdisciplinary education equips them to effectively bridge scientific innovation with regulatory compliance for medical device companies.
Recognized as a thought leader in the regulatory affairs space, with active participation as a committee member for Health Canada's SAC on Digital Health Technologies and as a speaker at prominent industry events like DIA and MedTech Canada. Their contributions highlight a commitment to advancing regulatory practices and sharing valuable insights with the life sciences community.
A seasoned Quality and Regulatory leader with over 22 years of extensive experience in the life sciences industry, demonstrating a remarkable career progression through senior roles at prominent organizations. Their expertise spans global QMS implementation, standardization, and certification, with a significant focus on medical devices. They have a proven history of leading successful regulatory strategies across North America, the EU, and APAC, including pivotal roles in eQMS rollouts, audits, and continuous improvement programs. Their experience includes managing complex regulatory submissions and ensuring compliance with evolving global standards, making them a valuable asset for any medtech firm.
A highly accomplished and certified Quality Assurance, Regulatory Affairs, and Clinical professional with over 22 years of dedicated experience in the life sciences industry. Raje excels in implementing, standardizing, and certifying robust Medical Device Quality Management Systems (QMS), including ...
With an impressive 23 years of experience, Raje Devanathan is a highly accomplished FDA regulatory consultant analyst uniquely valuable to medtech companies. Their deep expertise spans the entire lifecycle of medical device regulation, from robust Quality Management System (QMS) implementation (ISO 13485, MDSAP, FDA QSR) to successful global QMS strategies across North America, EU, and APAC. Raje's proven track record includes hosting multiple successful regulatory authority inspections (FDA, HC, EMA) and adeptness in complex submission pathways like 510(k), De Novo, and PMA, particularly for Class II and Class III devices including IVD and SaMD. Their proficiency in eQMS and digital compliance, coupled with a strong foundation in scientific principles from their MSc in Molecular Biology & Biochemistry, positions them as an indispensable partner for companies navigating stringent regulatory environments and driving digital transformation.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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