Quality Analyst & Regulatory Coordinator
A highly motivated regulatory and quality professional with a Master of Science in Regulatory Affairs from Northeastern University (GPA 4.0) and a clinical background as a Doctor of Pharmacy. Possesses hands-on experience in developing comprehensive regulatory strategies for Class II medical devices, from concept through to FDA submission, and authoring regulatory pathways for international market...
Experience: 2+ years
Seshasena Reddy Muli provides regulatory consulting services to clients in:
Possesses an exceptional academic background, combining a Master of Science in Regulatory Affairs from Northeastern University with a perfect 4.0 GPA and a Doctor of Pharmacy. This dual expertise provides a rare and valuable perspective, blending deep knowledge of regulatory strategy, international clinical trials, and FDA regulations (21 CFR Parts 210, 211, 820) with a strong clinical and pharmaceutical foundation. This robust educational framework equips them with the comprehensive understanding needed to navigate complex medtech compliance challenges effectively.
Recognized for excellence and innovative thinking within the pharmaceutical industry as a winner of the ISPE 2025 Hackathon, showcasing their ability to design forward-thinking manufacturing models. This achievement is complemented by practical project leadership, including designing a complete regulatory compliance strategy for a Class II medical device from concept through to FDA submission. This recognition highlights their capacity for both high-level strategic thinking and successful, hands-on execution.
Actively engaged in the regulatory and pharmaceutical engineering communities through memberships in the Regulatory Affairs Professionals Society (RAPS) and the International Society for Pharmaceutical Engineering (ISPE). This involvement demonstrates a strong commitment to continuous professional development and staying abreast of the latest industry trends, regulations, and best practices, providing valuable network connections and access to industry knowledge.
Demonstrates practical regulatory and quality assurance experience with medical devices, highlighted by their role as a Quality Analyst & Regulatory Coordinator. In this capacity, they conducted scientific analysis for a transdermal patch, authored a complete regulatory pathway for Canada with U.S. FDA comparisons, and ensured compliance with FDA and ISO 13485 standards. This hands-on device experience is complemented by a background in clinical pharmacy and medical operations, providing a holistic understanding of the healthcare ecosystem. Their experience in managing documentation, implementing corrective actions (CAPAs), and collaborating with cross-functional teams makes them a well-rounded and effective regulatory professional.
A highly motivated regulatory and quality professional with a Master of Science in Regulatory Affairs from Northeastern University (GPA 4.0) and a clinical background as a Doctor of Pharmacy. Possesses hands-on experience in developing comprehensive regulatory strategies for Class II medical devices...
Seshasena Reddy Muli offers a powerful combination of elite academic training and targeted hands-on experience ideal for medtech innovators. With a Master's in Regulatory Affairs (4.0 GPA) from Northeastern and a clinical Doctor of Pharmacy background, they possess a rare, dual perspective on product development. Their 2 years of focused experience have been spent developing comprehensive regulatory strategies for Class II medical devices, including authoring pathways for both the US FDA and Health Canada. This consultant excels in building regulatory compliance from the ground up, with deep expertise in QMS (21 CFR 820, ISO 13485), risk management (ISO 14971), and authoring 510(k) submission strategies, making them an exceptionally sharp and valuable asset for navigating the crucial early stages of market access.
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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