Suraj Ramachandran

Executive Director, Regulatory Affairs CMC - Medical Devices And Combination Products Lead at Organon

Suraj Ramachandran has extensive experience in regulatory affairs, particularly in the field of medical devices and combination products. Suraj currently holds the role of Executive Director, Regulatory Affairs CMC - Medical Devices and Combination Products Lead at Organon. Prior to this, Suraj worked at Merck as an Executive Director in the same field. During their time at Merck, they also served as a Director, Regulatory Affairs - Devices and Digital Health, where they provided regulatory support and guidance for various devices and digital solutions. Before joining Merck, Suraj worked at TransCelerate BioPharma Inc. as a Team Lead - Patient Technology Regulatory Affairs, where they led a team of regulatory affairs professionals. Suraj also has experience at Baxter Healthcare Corporation and CareFusion, where they held roles such as Regulatory Affairs Manager and Regulatory Affairs Specialist. Throughout their career, Suraj has demonstrated their expertise in regulatory compliance, strategy development, and mentoring.

Suraj Ramachandran's education history begins in 2004 when they enrolled at the University of Michigan to pursue a Bachelor of Engineering (B.Eng.) degree in Biomedical/Medical Engineering. Suraj completed their undergraduate studies in 2008.

Following their bachelor's degree, Suraj Ramachandran continued their education at the University of Michigan and pursued a Master of Engineering (M.Eng.) degree in Biomedical/Medical Engineering. Suraj graduated from the program in 2009.

In addition to their formal education, Suraj Ramachandran has also obtained various certifications. In 2019, they became a Certified Quality Improvement Associate (CQIA), Certified Six Sigma Yellow Belt (CSSYB), and Certified Quality Process Analyst (CQPA) from ASQ - World Headquarters. Suraj also obtained the Regulatory Affairs Certification (RAC) - Device from the Regulatory Affairs Professionals Society (RAPS) and the ISO 13485:2016 Lead Auditor - Quality Management System for Medical Devices from Exemplar Global, Inc. in the same year.

In 2020, Suraj Ramachandran obtained several additional certifications, including Certified Quality Auditor (CQA) from ASQ - World Headquarters, Regulatory Affairs Certification (RAC) - Drugs from the Regulatory Affairs Professionals Society (RAPS), and Professional Agile Leadership (PAL), Professional Scrum Developer (PSD), Professional Scrum Master II (PSM II), Professional Scrum Product Owner (PSPO), Professional Scrum Product Owner II (PSPO II), Professional Scrum with Kanban (PSK I), Professional Scrum with User Experience (PSU), and Scaled Professional Scrum (SPS) from Scrum.org. Suraj also obtained the ISO 22301:2019 Lead Auditor - Security and Resilience - Business Continuity Management Systems certification from Exemplar Global, Inc. and the GS1 Standards for Healthcare Provider and GS1 Standards for Product Data Excellence certifications from GS1 US.

Although the provided information does not mention Suraj Ramachandran's current academic pursuits, their extensive certifications indicate ongoing professional development and a commitment to acquiring additional knowledge and skills in their field.

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Previous companies

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TransCelerate BioPharma logo
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Timeline

  • Executive Director, Regulatory Affairs CMC - Medical Devices And Combination Products Lead

    June, 2021 - present