Technology is like a double-edged sword, bringing with it innumerable benefits but with inherent risks involved !

Sudipta Chakrabarti, our next pathbreaker, works as a Sr. Regulatory Affairs Specialist at a multinational Ultrasound company, playing a vital role across the entire spectrum, from R&D innovation to getting the product in the market.

Sudipta talks to  Shyam Krishnamurthy from The Interview Portal about the privilege of witnessing the use of products that she worked on, in various settings including trauma centers, emergency rooms, and sports clinics.

For students, the Regulatory field is an extremely dynamic and continuously evolving field. As new technologies are introduced, regulations change, and new standards and guidelines are developed.

Sudipta, tell us what were your growing up years like?

Many times, when I mentioned my profession as a Regulatory professional, I was met with puzzled expressions. It was clear that people were unsure about what my job entailed.

Despite being integral to any industry for centuries, Quality and Regulatory roles are not as widely recognized by the public as traditional professions. As a high school student planning my career, I was unaware of this profession. I didn’t dream of becoming a Regulatory professional from childhood. My aspiration was to work in the healthcare field, where my work could positively impact lives, either directly or indirectly. The story of how I entered the field of Regulatory is a journey.

Born and raised in a suburb of the beautiful city of Kolkata, located in the eastern part of India, I was immersed in a world known for its historical significance, rich culture, music, arts, and food. I was fortunate to grow up in a joint family culture. This upbringing played a significant role in shaping my personality, my perspective on life – both personal and professional – and ultimately, the person I am today.

My father, a civil engineer now retired, and my mother, a retired schoolteacher, were both deeply committed to their professions. Their dedication and the respect they earned at their workplaces have always been an inspiration to me.

In our family, education has always been the top priority. My parents did their best to provide us with diverse opportunities and resources. While they emphasized academic studies, they also encouraged us to explore other fields such as arts, music, literature, sports etc. From childhood, I had the chance to delve into both technical and creative fields and learned how to harmonize them. Growing up without the internet and with limited television access during weekends only, we were surrounded by books and art supplies for our leisure time. My cousins and I would celebrate the end of exams by painting together. Every year we organized family picnics during Christmas time and cultural programs during Diwali. Our parents provided support as needed; however, we were primarily responsible for arranging everything – managing the budget, delegating tasks to different people, coming up with an elaborate plan and executing it successfully. We often faced challenges such as managing expenses or meeting deadlines, but we worked as a team to overcome them. At that young age, we didn’t fully understand the value of these experiences but these learnings – how to face challenges, being creative and thinking outside the box to resolve issues – became invaluable later in different stages of my life.

More importantly, we learned how to deal with failures. It taught me one of life’s most significant lessons: it may not be possible to achieve success in every aspect of life. Often our failures teach us more than our successes do. It’s crucial to learn from our failures and use those lessons towards achieving future success.

What did you do for graduation/ post-graduation?

My interest in science began to develop during my middle-school years, with biology being my favorite subject. I was always fascinated by the human body, which I considered to be the most complex machine ever built. The intricacies of anatomy and physiology, and their connections to chemistry and physics, captivated me. I yearned to learn more and pursue a career in science and healthcare. However, I never aspired to become a medical practitioner. Instead, I was drawn to a field that would allow me to work in the corporate world while still pursuing my interests in science and healthcare.

I discovered the field of Pharmacy and decided to pursue it as it offered the opportunity to contribute to healthcare through work in the pharmaceutical industry. I earned a bachelor’s degree in Pharmacy from M.S Ramaiah College of Pharmacy under Rajiv Gandhi University Health and Sciences, Bangalore.

For my undergraduate studies, I had to relocate to Bangalore, approximately 1900 kilometers away from my hometown. This move brought with it many challenges – a new place, new people, and the experience of living away from home. 

The four-year Pharmacy curriculum was filled with vast knowledge from different areas including human anatomy and physiology, organic chemistry, inorganic chemistry, medicinal chemistry, pharmacognosy (study of medicinal plants), Pharmaceutical Jurisprudence (study of pharmaceutical regulations and laws) etc. The subjects were fascinating, and I quickly developed an interest in this field.

The curriculum was divided between theoretical and practical learning. I had the opportunity to work on various experiments in the laboratory while understanding the theory behind medicinal science, in a classroom setting. I learned how to make tablets, capsules, solutions, ointments etc., which sparked an interest in manufacturing.

During my undergraduate studies, I had the opportunity to work on a project at a pharmaceutical company. Here, I got the chance to work on a real manufacturing floor. It was an enlightening experience for me. The company developed all different types of medicines – from ointments and tablets to injectables. Everything I had learned so far in classrooms and laboratories came alive for me.

I came across Quality and Regulatory domains during this time and gained a basic understanding of these areas and their importance. My undergraduate days not only introduced me to the vast field of medicines and healthcare but also helped me become an independent and confident person, preparing me to face any challenges that came my way.

Later, I decided to specialize in Regulatory Affairs in Biomedical Sciences and earned a master’s degree in Science and Biomedical Regulatory Affairs from the University of Washington School of Pharmacy.

By the time I graduated from graduate school, I had not only gathered extensive knowledge in Regulatory Affairs but also understood its importance as well as the roles and responsibilities Regulatory professionals play – from product design and development to ensuring user and patient safety. Additionally, I was well-equipped with different tools and skill sets needed to begin my journey as a Regulatory Affairs professional.

Can you talk about some influences that led you to such an offbeat, unconventional and unusual career?

I’ve always had an interest in healthcare. To pursue this, I chose to study science during my high school years, majoring in Biology, Physics, and Chemistry, with Mathematics as an elective. This academic foundation helped me enter the Pharmacy program. My move into the Regulatory domain came much later when I decided to switch my career and joined a certification program before enrolling in a master’s program.

During the first quarter of my master’s program, I took a class in medical device design. This class introduced me to a new area and the exciting world of various technologies. As part of the class project, we were tasked with designing a medical device, developing a design specification, creating line drawings, and evaluating every aspect of medical device development. This included market research, design ideas, specifications, human factors, risk assessments, testing, and on the regulatory side, figuring out the medical device classification and understanding the regulatory requirements. I found this class fascinating and was drawn to the world of medical devices.

The master’s program offered focus areas in drugs, medical devices, in vitro diagnostics (IVDs), and biologics. However, it allowed students to concentrate on a particular area based on their interests. I designed my degree with a focus on Medical Devices. As I progressed through my Master’s program, the blend of technology and healthcare drew me more towards Regulatory Affairs in Medical Devices. I focused on projects and assignments related to medical devices and began to learn more about this industry.

The Master’s program was application-oriented. While we had traditional exams and homework assignments, most of the final exams involved working on different projects and presenting them in front of the class. To earn the degree, we were required to work on a project with a company, write a paper on it, and present it in front of the class and general audience.

I had the opportunity to work on a project at a big multinational Ultrasound manufacturing company. My project involved identifying the summary technical documentation in multiple countries, conducting a comparative analysis, and creating a knowledge base that identified the similarities and differences in requirements. During this time, I learned about Ultrasound devices, the regulations applicable to them, and their impact on healthcare.

The experience I gathered during my master’s program contributed towards developing my interest in medical devices and solidified my decision to choose Regulatory Affairs in Medical Devices as my career path.

My key influencers

Growing up, my key influencers were always my parents, my brother, sister-in-law, and my family. I was blessed with a progressive-minded family. Being the only girl child in my family, I received every possible opportunity that my brother and other cousins did. The environment in which a child grows up plays a crucial role in shaping his/her future and personality. The open, unbiased, and gender-equal environment provided by my family encouraged me to dream big.

Even though my brother studied in boarding schools, and we didn’t get many opportunities to stay together, he was always watching over me. I still remember when I was preparing to go to college and was scared to move far away from home, he gave me the most important advice I needed at that time. He told me, “Staying on your own will teach you a lot.” His advice helped me cope with my fear and prepared me for stepping into the outside world.

For my master’s degree, I had to take a student loan. Without my sister-in-law’s support, it would have been impossible for me to get the student loan and chase my dream. My family always supported me when I needed them the most without imposing their thoughts on me.

After my marriage, my biggest supporter has been my husband. He helped me by supporting my decisions, such as taking the time to pursue my master’s degree and making the career choices I wanted to make. More importantly, he made sure I could continue to be the independent person I had worked towards becoming all my life.

In addition to my family, I have been blessed with great mentors, professors, managers, and co-workers who have open heartedly welcomed me into the world of Regulatory Affairs. They taught me new skills and trained me to ensure that I could achieve success in my career.

I am grateful to all my teachers from elementary school through high school who helped me build the strong foundation I needed for a successful career.

It would be impossible for me to achieve success in my profession without the continuous support I receive from my husband and kids every day. Additionally, the positive vibes I receive from my extended family fuels me towards achieving my career goals.

Key turning points

As I mentioned earlier, I didn’t initially plan to become a Regulatory Professional, mainly because I wasn’t aware of this profession at the time. My path towards it evolved as I progressed in my career. That being said, I’ve always had an interest in healthcare. My fascination with science and healthcare guided me on my journey. My interest in technology was cultivated during my master’s program, which steered me towards the career I ultimately chose.

I’m grateful that my journey has led me to where I am today. I have the privilege of working in the healthcare industry, contributing to the development of safe and effective medical devices equipped with cutting-edge technologies. These devices are used by thousands of users and benefit millions of patients. My profession allows me to live my dream. 

Tell us about your career path

My interest in science and healthcare led me to the field of Pharmacy. After graduating, I wanted to pursue a master’s degree. However, I got married early and moved to the USA. Until then, I was not aware of the nature of the Pharmacy profession in this country. I was more interested in working in the industry than as a pharmacist. I soon realized that I needed to make a career switch, but I wanted to stay in healthcare.

During this time, my husband was interviewing with different universities for his job in academia. While preparing for my GRE and TOEFL exams, I started exploring different options. Nothing really attracted me until I came across the master’s degree in Biomedical Regulatory Affairs offered by the School of Pharmacy at the University of Washington. However, as I was on a VISA at that time, I was considered an international student as per the regulations. The application timeline for international students was different and I had missed it. The program manager recommended the certification program offered by the same department.

I decided to join the certification for Clinical Trials as it would give me the opportunity to explore this area and help me determine if I would like to pursue it before committing to the master’s program. I soon developed an interest in this field and realized that this profession would allow me to stay in the healthcare field.

After completing my certification, I applied for the master’s program and was thrilled to be accepted.

Right after graduating from the master’s program, I joined a small consultancy company as a Regulatory Affairs and Compliance Specialist. In this role, I had the opportunity to work in the Regulatory field by developing a Regulatory knowledge base for the consultancy firm and also work in Compliance Engineering at a client site. Compliance Engineering is an integral part of device development for medical devices with electrical connections. In this role, I got involved in safety testing and working on audits with the safety agency etc. This experience added a new dimension to my career. During this time, I also mentored a Regulatory Affairs master’s student which helped me improve my leadership skills significantly.

After working at the consultancy firm for several months, I joined a big Ultrasound company as a Regulatory Compliance Specialist and continued working in Compliance Engineering for several months before moving to a Quality and Regulatory focused role as a Regulatory Affairs Specialist. In this role, I had the opportunity to work in both Quality and Regulatory domains. On the Quality side, I worked on Complaints handling and Audits. I participated in several external audits, and as a certified lead Auditor I conducted internal audits. During this time, I learned a lot about Quality and its role in device development and quality management.

In my Regulatory role, I was responsible for Regulatory submissions in international markets as well as worked as a Regulatory lead for several product developments. In this role, I had the opportunity to work in over 40 countries across the world.

During my time here, I was promoted to a Sr. Regulatory Affairs role where I focused more on USA, EU, and Health Canada submissions, developing tools, working as a Regulatory lead for a new Ultrasound Device and training others.

After spending over 8 years, I joined my current company, a big multinational Ultrasound manufacturer as Sr. Regulatory Affairs Specialist, where my journey began as an intern at the start of my career. In my current role, I work on app-based Ultrasound devices and cutting-edge technologies.

How did you get your first break?

My first significant opportunity came right after I graduated from the master’s program. The knowledge I acquired from the master’s program, coupled with the experience I gained from the project I worked on during my master’s program, paved the way for me to secure my first job in Regulatory. This marked the beginning of my professional journey in this field.

What were the challenges? How did you address them?

Challenge 1: One of the most significant challenges I faced early in my career was a language barrier during my undergraduate years. Until college, I had studied all subjects, including mathematics and science, in Bengali. The Pharmacy curriculum was filled with various scientific terms. While these terms were not unfamiliar to me, I only knew their Bengali equivalents. Initially, it was very difficult for me to keep up with the pace of the course. I was in a new place with a completely new setup and had to manage many other things along with my studies.

At first, I didn’t know how to resolve this problem. However, my ability to face challenges came in handy. I soon devised a strategy to overcome my limitations. A medical dictionary became my best friend during this time. I spent a lot of additional time and put in a lot of effort to understand the terms, lectures, and notes provided by the professors.

Additionally, I started participating more in class discussions, signed up for class presentations, and engaged in any other activities where I could practice more and also improve my communication skills.

My hard work and the strategy I adopted paid off. So much so that my father later shared with me that one of my professors was surprised to learn that I was not from an English-medium school.

This experience taught me an important life lesson: there is no shame in admitting “I don’t know”. It’s impossible to know everything; there will always be limitations. But it is possible to learn new things at any age and at any time, and with effort, one can overcome any limitations. It’s important to accept when you don’t know something. Then learning becomes much more fun and success will come knocking at your door.

Challenge 2: Another challenge I faced during my high school and college years was the lack of access to unlimited resources. The internet was new and not everyone had access to it. Finding information about anything was difficult. We mainly had to depend on books, which may or may not have been up to date with all information.

When I decided to join Pharmacy school, I didn’t have a lot of information about this field. My dad helped me gather as much information as possible. I had to take a risk and I’m glad I did. It’s important to take risks sometimes in life if you are mentally prepared for it and ready to deal with any challenges life might throw at you.

If you keep your mind closed, a small barrier may look like a huge mountain. But if you keep your mind open and are willing to take risks, you can turn treacherous roads on a huge mountain into a scenic view.

Challenge 3: Financial challenges can become a significant roadblock, especially for international students. Fortunately, when I was in grad school, I didn’t have to worry about housing and food as my husband supported me in these aspects. However, the Master’s degree was a professional degree and there were no scholarship opportunities available. I had to apply for a student loan to pay the tuition fee.

There was only one bank offering the student loan I needed. However, I required a guarantor to ensure that if for some reason I was unable to pay back the loan, my guarantor would cover it. Due to his VISA status, my husband couldn’t be my guarantor and my brother was already on a student loan himself. Without the loan, I couldn’t pursue the Master’s degree.

My sister-in-law stepped in to help by becoming my guarantor. As I mentioned earlier, without her support, I wouldn’t have been able to embark on the career path I have today. I needed formal training to get into the Regulatory field. For me, everything worked out as I had family in this country to support me.

For anyone planning to study abroad, my recommendation would be to ensure that along with everything else, you have planned for the financial support you need to complete your degree.

Where do you work now? What problems do you solve?

I currently work at a big multinational Ultrasound company as a Sr. Regulatory Affairs Specialist. The Regulatory domain plays a vital role from the start of innovation to getting the product in the market. In my current role, I am responsible for guiding cross-functional teams with Regulatory requirements in the targeted markets, keeping them updated with changes to regulations, standards, and guidance, as well as identifying the impact of any new regulations or requirements on existing and new products. I am also responsible for developing regulatory strategies that assist the company with marketing clearances or approvals while ensuring the product is safe and effective for users and patients. Additionally, I work with Regulatory bodies on Regulatory submissions to gain marketing clearance for Ultrasound devices. 

What skills are required in your role? How did you acquire the skills?

The Regulatory profession is a highly specialized field. Working in medical devices, my job requires me to have an in-depth knowledge of regulations, local and international standards, and guidance applicable to the devices I work with. Even though I specialize in the Regulatory role, my job requires me to have a good understanding of other cross-functional areas in order to provide guidance during design and development and beyond. For submission purposes, I am required to work with different regulatory bodies. Good communication skills, attention to detail, and good organizational skills are integral parts of my job. Additionally, problem-solving ability, creative thinking, and the ability to come up with different strategies and project management are important skills required to perform Regulatory responsibilities.

During the master’s program, I took classes to improve some of the above-mentioned soft skills as well as understanding project management. I was introduced to different regulations, standards, and guidance. However, the Regulatory field is a continuously evolving field. As new technologies are introduced, regulations change, and new standards and guidelines are developed. It is important to stay up to date in order to keep up with this fast-moving field. To keep me up to date I constantly invest myself in learning.

It can be challenging for someone new to get into this field. However, it is not impossible. In the past, there were not many formal training programs available in this field. People from different science, engineering, and healthcare backgrounds made their ways into Regulatory. On-the-job training played a very important role, which is still as important as it was before. However, now there are formal training programs, certifications, master’s degrees offered by different universities either in Regulatory fields or Regulatory fields integrated into other related healthcare fields. These formal courses and degrees provide basic training on Regulatory which is well acknowledged by the industry.

What’s a typical day like?

A typical day in my job involves a mix of activities. This includes working with the design and development team on an upcoming product release, ensuring regulatory requirements have been addressed, and developing strategies for future submissions and releases. I also assess proposed changes and work on submissions or deliverables for upcoming releases. Collaboration is a key part of my role, and I often work with internal and external Regulatory teams and project teams. My day also involves attending meetings, reviewing, and approving program deliverables as well as marketing documents. I assist in resolving issues that require involvement from the Regulatory department. In summary, every day at work is eventful and filled with diverse tasks.

What is it you love about this job? 

There are several aspects of my job that I truly love. The continuous changes in regulations make my job both exciting and interesting. The ability to work on cutting-edge technology and contribute towards bringing advanced devices to our users and patients is incredibly rewarding. However, the most important aspect that I love about my job is the opportunity it provides me to ensure that our devices are safe to use. This responsibility is at the core of my role and is something I take great pride in.

How does your work benefit society?

In my role, I am involved from the initial stages of the design and development of an Ultrasound device until it reaches the users and patients. I assist in the design and development of the Ultrasound devices by guiding the cross-functional teams to ensure that the device meets the Regulatory requirements in the targeted markets. Concurrently, I am responsible for presenting these new, advanced devices to Regulatory bodies to gain clearance or approval for marketing, enabling users and patients to access these advanced devices. Additionally, I also shoulder the responsibility of ensuring that the marketed device is safe and effective.

Tell us an example of a specific memorable work you did that is very close to you!

I’ve had the privilege of witnessing the use of our products in various settings, including trauma centers, emergency rooms, and sports clinics. However, the most memorable experience was when these devices were used on me during my pregnancy. Seeing my babies for the first time through a device I worked on was an amazing feeling. It’s hard to put that feeling into words. I felt so comfortable having those devices used on me because I knew that patient safety was the utmost priority for my company.

Your advice to students based on your experience?

My advice to students is that it’s important to have a plan for your future. Identify your interests and ensure you are well-prepared to explore that field. There are a vast number of resources available to learn about different fields. Utilize these resources to plan your career. Sometimes, things may look great on paper, but they may not work out for you in real situations. Reach out to experts working in these fields to gain a good understanding. If you’ve found your area of interest, make sure you have in-depth knowledge in that field, which will help you build a strong foundation. Also, prepare yourself for any unexpected turns in your career.

Future Plans?

I plan to continue working in the Regulatory field for medical devices and aim to gain more knowledge and expertise in this field. The prospect of learning about new technologies and the evolving regulations around them always excites me.