Applicant: Rishu Rathee

Degree Pursued: Master of Technology (Biomedical Engineering)

Designation: Senior Technical Data Associate (Medical Devices)
Organisation: Central Drugs Standard Control Organisation,
Government of India

STATEMENT OF PURPOSE

It gives me immense pleasure to write this statement of purpose for MS in Regulatory Affairs for Drugs,
Biologics and Medical Devices in your illustrious university. As a candidate for Post-graduate study in
Regulatory Affairs, I am keen to delve deeper into Medical Devices, Drugs and Biologics in order to
hone my academic skills in addition to helping people lead healthier lives by using this knowledge in
bioscience, health care and medicine. The integration of technology and entrepreneurship with medicine
necessitates complex regulatory compliance for ensuring that new medical devices are just innovative but
safe. The advancement in the field of medicine brings its own set of risks requiring ethical safety
measures to optimise health and performance. Keeping this very thought in mind, coupled with my
experience of regulatory affairs in the Indian medical device industry, I wish to apply for this innovative
and specialized course.

As a Biomedical Engineer from MD University and a Masters in Biomedical Engineering from D.C.R
University of Science & Technology, I had the opportunity to explore subjects ranging from Human
Anatomy and Physiology, Biomaterial, Biomedical instrumentation and Biomechanics to Network
analysis, Design and Digital electronics. This dual specialization in Biology and Technology laid
emphasis on application of engineering principles to natural sciences, building a solid foundation upon
which to build my career .Consequently, I began my career exploring mysteries of diseased and
healthy human brain networks using latest software and coding techniques as a Project Assistant
in Computational Neuroscience & Neuroimaging Laboratory at the National Brain Research
Centre under Professor P.K Roy. While the work was intriguing and the resultant findings were
published in SAGE journal, my career ambitions were focused on a more dynamic role
encompassing the overall development of a medical device’s life cycle encompassing
manufacturing, quality control, market surveillance and RD.

My academic excellence and deeply ingrained research skills were duly recognized and I had the honour
to be selected as one of the first five Research Associates chosen for the Indian government’s first
Post Market-Surveillance Programme for Medical Devices, the Matero Vigilance Programme of India
(MVPI). The work entailed identifying, collecting, analyzing and relating (root cause analysis) adverse
events associated with medical devices from various clinical departments of the All India Institute of
Medical Sciences, New Delhi. Here, I acquired firsthand knowledge of the regulatory environment
relating to drugs and medical devices along with vital workplace essentials: teamwork, out of the box
thinking, collaborative research and synergizing amongst doctors, patients and businesses. Armed with
this invaluable experience, I continued with the advancement of my career in core regulatory affairs with
Indian Regulatory Body for Drugs and Medical Device at CDSCO. These initial months found me
actively involved in reviewing and analyzing technical dossiers for grant of registration certificate and
import license of medical devices by stakeholders across India. Knowledge of device design,
manufacturing flowcharts stability data, sterilization protocols, risk assessment, labels & ISU,
biocompatibility and Post Market surveillance data has given me the necessary edge to leverage this
learning in the domain of Regulatory affairs.

Medical Devices regulation in India is in its fledgling stages where the Drugs & Cosmetic Act 1940
establishes the legal framework for operations. While the standards for drugs and biologics are well
established and defined, the medical devices regulatory framework is still in formation. The Indian
healthcare sector is poised on the cusp of transformation; high demand for quality and cost-effective
medical facilities for the burgeoning population as well as advancement in technology is driving the
current growth in this sector. A paradigm shift in perspective and a strong regulatory framework are thus
essential to keep pace with innovation in Indian healthcare landscape. Thus, an expertise in leading-edge
research and developed global regulatory policies, especially the US FDA, will give the necessary
impetus to propel me into a career in regulatory affairs.

My quest for the ideal course in this domain led me to Northeastern University, Boston. The university is
a trail blazer in every field, with the finest professors who are global leaders in their respective fields,
laying emphasis on experiential learning and innovation. .The MS in Regulatory Affairs combines novel
product development with clinical evaluation as per International Standards, making it one of the most
dynamic and comprehensive programs in regulatory affairs. The exhaustive and pioneering curriculum
together with elective subjects like Quality system regulation makes this program an ideal choice for a
successful career. While there will be many worthy applicants for this course, I genuinely believe that my
background as a Biomedical Engineer, academic excellence and relevant experience in interdisciplinary
fields will add value and make me a tailor made candidate for this course. Moreover, my dedication, and
passion for making a difference in the lives of people, specifically in Healthcare will help me to add value
Not only will the program complement my Biomedical and research experience, it will enable me to think
outside the ‘lab’ and equip me with the requisite skills needed to deliver new medical products with safety
and assurance, transforming the way people are cared for. The prospect of an MS from Northeastern
University will help me to make a mark as a global leader in regulatory affairs and provide the necessary
framework to chart new frontiers in effectively using this knowledge for betterment of the society at
large. It will indeed be an honor to be accepted at your pioneering University, thus, it is with keen
anticipation and sincerity of purpose that I apply for this transformative program.