Medical devices and drugs need to tread a fine line between achieving the desired efficacy through innovation and ensuring adequate patient safety through regulatory processes.

Jaishri Meganathan, our next pathbreaker, Senior Regulatory Affairs Specialist at Philips Remote Diagnostic Technologies (UK), works on product compliance with respect to safety, reliability & effectiveness.

Jaishri talks to Shyam Krishnamurthy from The Interview Portal about the cross-disciplinary nature of her job and the diversity of challenges in bringing new products into different markets based on local medical device regulations.

For students, the field of healthcare is not just about research & development, but also about bridging the gap between technology and reality !

Jaishri, can you tell us about your background?

I was born & brought up in Chennai, India. My father is a Senior Accountant at a private firm and my mother is Head of Accounts in public service. My parents supported my interests and did not force their wishes on my career choices or education.

I am a Biomedical Engineer and did my PG in Regulatory Affairs. My Regulatory Affairs career brought me from India to the UK via Brazil.

What did you do for graduation/post-graduation?

I did my bachelor’s in Biomedical Engineering at VelTech College affiliated to Anna University and did my PG in Medical Device Management (Regulatory Affairs) at Institute of Good Manufacturing Practices, India (IGMPI, Delhi).

What were the drivers that led you to such an offbeat, unconventional and unusual career?

Like everyone I was preparing hard to join medicine. But I couldn’t get through the government medical college that I wanted to join. So, I selected a similar stream & an alternate path to join MBBS in the 3rd year through lateral entry and that’s how I took up Biomedical Engineering. However, I was totally fascinated with the instrumentation and technologies that were used in Biomedical Engineering. I selected the most challenging project that applied neural networks called “Brain Computer Interface” to activate the limbs of paralyzed patients. When I was working on the project, I saw how technologies like neural networks & signal processing helped paralyzed patients in becoming independent. That’s when I strongly decided to pursue a career in instrumentation by giving up my earlier plan and dream of becoming a doctor.

How did you plan the steps to get into the career you wanted? Or how did you make a transition to a new career? Tell us about your career path

I did not have a proper direction, guidance, or industrial exposure other than getting an internship opportunity at hospitals. Colleges have always focused / prioritized on IT companies during placement. Also, Biomedical Engineering is the emerging child among other engineering specializations. So, landing my first job (excluding hospitals) in a core company was really challenging.

3 months after graduation, I started my career as a Regulatory & Design Engineer at DyAnsys India Pvt Ltd, a medical device start-up that was founded in 2002. They are the patent holders for a device called ANSiscope, which monitors the Autonomic Nervous Systems and helps in the early detection of Autonomic Neuropathy ( occurs when the nerves that control involuntary bodily functions are damaged) & diabetic neuropathy. Today’s most trending machine learning technology has been used in this system since 2002.

As a Regulatory & Design Engineer, my role included maintaining the quality management system for the organization, maintaining & updating the product design documentation, performing product license registration in many countries to open up sales, liaisoning with government agencies, certification bodies for product approvals, helping in firmware/software verification & validation by writing test cases.  

I learnt a lot on the job here. The company  leadership & my colleagues were extremely encouraging. After completing my probation of 3 months, I got a chance to try my hand at submitting regulatory filling called 510(K) to the Food & Drug Administration (FDA), USA for a Peripheral Nerve Stimulator. Once the device was cleared, we had our first ever FDA inspection on the manufacturing site. The leadership again provided me an opportunity to front end and handle the inspection which lasted for a week and the product was cleared without any compliance issue. At the same time, I was appointed as the Management Representative (MR) of the organization. This was a turning point in my career as it opened a ton of opportunities for me, since very few get a project like this to work on. I must say that everything was falling in my path at the right time.

I spent the next 3 years as Regulatory Affairs Specialist & MR working closely with the cross-functional teams including quality control, R&D, production, procurement, supplier quality, clinical teams on NPI & sustainability projects (design changes).

I had a great opportunity to learn many things very early in my career. Exposure to design changes in the product and market expansion for sales in many countries diversified my learnings. Due to design changes, we had to submit another filing to the FDA and continued to do the same with the European notified body. During this time, I was managing Sterilization Validation, Sterility Testing with the testing lab. I was pulled into supplier evaluation and established a new process at the supplier premises & expanded their scope to test the medical devices. Later, I was handling the QMS (quality management system) transition project all alone and training the entire organization to implement the system & get certified.

The wide range of knowledge that I had acquired and the groundwork that I had done paved the way for my next job. I joined as a Regulatory Affairs Specialist in the Clinical Informatics business of Royal Philips at Brazil. Being adventurous in nature helped me to relocate to Brazil along with my husband.

At Philips, I have worked on a stand-alone medical device software, making the product & process fully compliant with the new European Medical Device Regulation. Again, this was the most sought after skill during that time in order to help businesses release their products in the European Market within a certain deadline, since it was a do or die situation for the sales. I was guiding & implementing end to end requirements. This project added real weightage to my resume.

Two years later, I had an opportunity for an internal transition within the company. I moved to the Remote Diagnostics Technologies business of Royal Philips (UK) as a Senior Regulatory Specialist. Here we deal with diagnostic (patient monitors) & therapeutic (automatic external manual defibrillator) devices used in pre-hospital environments like ambulances, flights, yachts etc. In my current role, I help in guiding the business integration by implementing corporate level processes, helping in clinical evaluation for all the products, design changes compliance etc

How did you get your first break?

I consider my first job (as a fresher) at DyAnsys India Pvt Ltd as my first break. I was searching for jobs in core companies (medical device manufacturers) after my exams, when I came across a job opening for freshers in Biomedical Engineering posted in Naukri.

I always thought about working in R&D, but when I joined my first company, I didn’t have any idea as to what regulatory affairs was. Then I started to enjoy what I was doing. 

What were some of the challenges you faced? How did you address them?

Challenge 1:

Finding the first job without campus placement especially in the core area, without having any contacts, was a big challenge. Until I got my first job, I didn’t want to be idle, or lose interest and become lazy. So, I was teaching mathematics to +1, +2 CBSE students for 3 months even though my parents didn’t wish me to.

Challenge 2:

Handling the big change from a small startup company to a multinational conglomerate, Koninklijke Philips N.V was another challenge.

Even though I was technically strong, front ended & hosted the FDA inspection, the way of working, the team set up, different reporting lines, tools used for any activity and getting through the most sophisticated processes was challenging and took me a month to get my hands on.

Challenge 3:

Overcoming the language and cultural barriers was a major challenge I faced when I moved to Brazil. Apart from the office space, there is no English spoken outside and no Indian foods or groceries were available for a foodie like me.

However, I came out of my comfort zone easily due to my adventurous in nature and learned basic Portuguese to live. I love Brazilian food. All these wouldn’t have been possible without my husband and the amazing team friends that I got, they supported me a lot.

Challenge 4:

Relocation comes with its own challenges, and it became even more challenging to avail visa during the pandemic while being pregnant. It was totally frustrating to wait for a long time just to get the visa appointment, not to mention the multiple cancellations due to lockdowns. I kept myself prepared and calm because I didn’t have any other option while being pregnant. Philips supported me through a smooth transition from Brazil to the UK.

Where do you work now? What is your role as Regulatory Specialist?

I work at the Remote Diagnostic Technologies (RDT) Business in Philips as a Senior Regulatory Affairs Specialist. RDT is the leader in the Emergency Care & Resuscitation market. We manufacture and sell Patient Monitors, Automatic External Defibrillators and Command Center.

My work is mainly focused on getting the products certified for safety & effectiveness in the countries where the business intends to sell, by making sure the product is in compliance with local medical device regulations. The most interesting part is planning a strategic roadmap for product release.

Can you explain what is regulatory affairs?

Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. A new class of professionals emerged to handle these regulatory matters for companies.

The primary role of Regulatory Affairs is to provide strategic and technical advice to the medical device / pharmaceutical companies, right from the development to the successful marketing of the product.

A career in Regulatory affairs is one of the versatile professions one can ever come across because it provides diversified employment opportunities that too at various levels. Even though Regulatory Affairs is one of the most interesting and rewarding careers, still it has its own challenges.

What skills are needed for your role? How did you acquire the skills?

Soft skills like communication and stakeholder management are the key, as we deal with government agencies & certification bodies. I acquired skills from all the stages of my career and by taking courses in LinkedIn as well. I have always been a self-motivated learner and like to keep myself updated in my career. I attend many webinars on medical device regulations, latest ISO standards, and latest technologies that help me think out of the box and be successful.

When it comes to beginners, they can acquire soft skills from LinkedIn Learning and any technical skills from Udemy, Skillshare etc. many of which are free of cost

What’s a typical day like? What problems do you solve?

A good portion of my work goes in developing regulatory plans and providing regulatory input which ensures regulatory requirements are met and maintained throughout the product marketing lifecycle, including new product introductions (NPI) and product changes.

I am also involved in coaching and mentoring the team members, meeting with internal stakeholders from various teams to help guide them, discussing product compliance & shipment related challenges, helping with strategic decisions to release or not in specific countries during hard times, guiding & steering the R&D team sometimes to follow proper design control requirements.

I also participate in all review board meetings, where I provide quality & regulatory guidance related to CAPA, reporting, design change reviews, etc.

What is it you love about this job?

I love this work as each day is different and so are the challenges we deal with.

How does your work benefit society?

Working in the medical device industry is directly impacting people’s lives with the product we manufacture. Especially when dealing with product compliance, I make sure that we release products that are safe, reliable, effective and do not cause any harm to the users. This gives me a lot of satisfaction at the end of the day.

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

A memorable work that is close to my heart is the update done on the company’s QMS by reading & interpreting requirements on our own without external training and preparation. I did this to handle the on-site FDA inspection and this was done successfully according to plan. This was the biggest learning experience that I enjoyed. The next day was a big day, as I got promoted on my birthday.

Your advice to students based on your experience?

My piece of advice to the current students is, “What you get is not always what you want or desire, sometimes plans might change”. Be prepared always.

Acquire some soft skills, get certified in the basic office tools.

Don’t lose hope, all you need is patience and perseverance to deal with it.

The beginning of your career might look overloaded but that is the place where you can learn & gain lots of experience. After a few years, this will change.

I also would like to advice students not to join their masters immediately after bachelors if you don’t have definite plans in place. Start working and try to understand what you like the most & identify your strengths, etc. Then do a masters accordingly. Because what you see on the very first day of your work is not what you study for 4 years, especially in India.

Future Plans?

I always want a role where I can consistently learn and grow professionally, and create a strong impact on the organization’s development or growth.

One of my wishes is to become a career coach and mentor.