Introduction

My name is Hiral Vora, and I am originally from Mumbai, India. I came to the United States in September 2017 to pursue a master’s degree in Regulatory Affairs at Northeastern University, Boston. Since then, I have been in this city and loving it so far. Interestingly, I am one of those who had a challenging time in deciding my future pathway and pursued three master’s degrees in biotechnology field, Regulatory and Business administration. But I am also a firm believer that no education goes to waste, and I am sure this education is going to help me in some way or the other in future. I am currently working as a Lead Quality and Regulatory Affairs Specialist at a medical device software company in Boston making sure that the software is available to patients in need for the betterment of their health. Let me walk you through my journey from being a student to navigating the twists and turns of the medical device industry. While I was pursuing my master’s in biotechnology, I had to work on a thesis. I joined one of the prestigious hospitals in Mumbai to complete my thesis where I worked with numerous PhD students as well. Picking regulatory was not a random choice. While working in the lab, I realized it wasn’t my jam. That's when my guide at the time suggested I check out quality control and assurance. I did speak to a few people, and it clicked! That led to Northeastern University for my masters in regulatory affairs. I discovered that my passion lay in making sure the healthcare industry and products met the rules and guided me towards the excited world of regulatory affairs. Northeastern University wasn't just a quick stop; it completely changed the game for me. The program there didn't just teach me the nitty-gritty of rules; it also equipped me with the practical skills I needed to deal with the always-shifting medical device regulations. Northeastern University was a pivotal moment for me because I did not have any experience with regulatory, so landing a co-op was quite challenging for me. I tried to make the most of my internships and experiential network projects at the university and learn as much as possible to ensure that I can land a job I love after graduation. Northeastern has many such opportunities for a starter to gain hands-on experience before they step into the real world, which has been very helpful to me especially. My co-op was in a medical device company and since then I have not looked back. I love medical devices and have always worked in the medical device industry. I've changed jobs a few times, always chasing better opportunities. But here's the thing – I've stuck to smaller to mid-sized companies. In these places, you get to do a bit of everything, wear different hats, and soak up a ton of knowledge. It's been a game-changer for me. Now, in the regulatory world, there are two big fields – quality and regulatory. They might sound similar, but they're quite different. Lucky for me, I've had the chance to dive into both. Right now, I'm juggling both roles, figuring out where I want to go next and grow. It's a bit like standing at a crossroads, and I'm taking my time before making the call.

Regulatory Affairs

career options

Here are some different career options one can explore in Regulatory Affairs. Keep in mind that these roles might mix or have specific areas to dive into, giving you more chances to specialize and move up. But the main deal in the regulatory world is making sure that medical devices, drugs, or biologics follows the rules. It's all about ensuring they meet the standards and keep everyone safe – especially the patients or users.

1
Regulatory Affairs Specialist
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Quality Assurance (QA) Specialist
3
Clinical Regulatory Affairs Manager
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Regulatory Affairs Consultant
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Regulatory Compliance Specialist
6
Government Regulatory Affairs Officer

Regulatory Affairs

 skills

What are the main hard skills you use on a daily basis in your current job?

1
Regulatory knowledge

Understanding regulations and guidelines specific to the industry, region, and product type is fundamental. This includes knowledge of FDA regulations, EU directives, and other global regulatory frameworks. In the world of regulatory affairs, the key is to constantly adapt to evolving regulations, which shift over time alongside technological advancements. Staying updated on these changes is crucial, especially when tailoring regulatory strategies for companies. This proficiency develops gradually. While you can study various regulations, the ability to apply them effectively in specific situations is a skill honed over time. It's an ongoing process of learning and professional development, especially when tackling emerging regulatory challenges. Furthermore, diverse products are subject to distinct regulations, and these can vary across different countries. Understanding and applying these regulations involve a comprehensive process.

2
Technical Writing

The ability to communicate complex scientific and regulatory information in a clear and concise manner is crucial. Regulatory professionals often draft documents for submissions, including protocols, reports, and summaries. Acquiring technical writing proficiency in regulatory affairs involves formal education and practical experience. With time and supporting drafting various submissions tp regulatory authorities, I have learned to articulate complex scientific and regulatory details clearly and succinctly and I am still learning. This skill is indispensable in especially when you want to grow and working in regulatory submissions which include protocols and reports, device descriptions and other similar things. Routine tasks, such as maintaining quality management systems, demand the creation of precise documents like standard operating procedures and compliance reports. Technical writing is equally essential when collaborating with cross-functional teams, ensuring effective communication of regulatory requirements. Additionally, this skill proves crucial when responding to regulatory queries, requiring concise and well-structured explanations to navigate the complexities of compliance seamlessly.

3
Risk Management

Identifying and mitigating risks associated with regulatory compliance is a key skill. This involves conducting risk assessments, developing risk management plans, and implementing strategies to ensure regulatory compliance. In my opinion, being good at handling risks is super important for someone in regulatory affairs. Even though there are experts and tech teams figuring out what could go wrong with a product, it's the regulatory folks who get the final say in identifying and mitigating those risks. The main goal of regulatory authorities is to make sure companies know what risks come with their product and that they've done enough to make those risks acceptable. If there's no good way to make things safer, the company has to weigh the risks against the benefits. Regulatory folks always focus on risks first and look at them really closely. So, they need to be skilled at understanding all the risks and making sure everything follows the rules before a product hits the market. I'm still learning about this risk management myself—it's a bit tricky. In big companies, there are special teams just for dealing with risks, but in smaller ones, it's usually the regulatory team working with other teams to handle it all.

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5

What are the main soft skills you use on a daily basis in your current job?

1
Communication skills

Clear and effective communication is vital for interactions with regulatory agencies, cross-functional teams, and stakeholders. This includes writing reports, preparing submissions, and participating in meetings. Communication is hands down the most important skills you need to have as a regulatory specialists. It is crucial when preparing clear and persuasive regulatory submissions, collaborating with cross-functional teams, engaging stakeholders, interacting with regulatory agencies, and managing crises. The ability to convey complex information transparently is essential for building positive relationships and ensuring regulatory compliance. For example: when you need to explain regulatory strategy to investors or top management, you need to be specific and accurate about the details you share. Not only them, when explaining the engineers why they need to a particular thing per regulatory standards is very important so they can understand its seriousness. Also, when in meetings with regulatory authorities, these skills are quite important. Continuous refinement of communication skills is vital for navigating the multifaceted challenges within the regulatory landscape especially in helathcare sector because the success of the company depends on the product and the product can be marketed only when approved/cleared by regulatory authorities that regulatory specialists are responsable for.

2
Project Management

Effectively managing regulatory projects, including timelines, resources, and deliverables, is crucial. This skill helps in coordinating cross-functional teams and ensuring timely regulatory submissions. Project Management skills are helpful for setting timelines, sharing tasks, and handling resources. For example, we are currently working on a regulatory submission for a new product. With Project management skills, I can plan the steps, set clear goals, and make sure everyone sticks to deadlines. When dealing with different teams, like research, quality, and engineering, these skills help coordinate efforts smoothly. In tight situations, like meeting quick submission deadlines or getting ready for audits these skills can be helpful as they can be used to be more organizaed, set goals, manage tasks, monitor progress and complete them in timely manner. It is also useful in balancing workloads and optimizing resource utilization that contribute to project efficiency. It's like being a captain, steering the ship to success in the complex world of regulatory affairs.


3
Adaptability

Given the dynamic nature of regulations, being adaptable is crucial. Regulatory professionals need to adjust to evolving requirements, industry changes, and unexpected challenges. A great example of this is the development of regulations for softwares as medical devices. A decade ago, the prevalence of software in medical devices was not as widespread as it is today. Consequently, regulatory authorities faced a learning curve, and the regulations in place were not fully mature. As awareness grew and challenges associated with software as medical devices emerged, regulatory bodies adapted. New regulations were implemented for fresh submissions, and staying uninformed about these updates could lead to submission denials for regulatory specialists due to non-compliance. Today, there are multiple guidances and regulations specifically for softwares that companies have to comply to for successful submissions and approval. This underscores the importance of staying abreast of evolving regulatory landscapes in order to ensure compliance and successful submissions.

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5

Hiral

’s personal path

Tell us about your personal journey in

Regulatory Affairs

:

Every person has a unique job experience, and external factors play a major role like COVID or recessions. It is rare but it is the reality of life. Luckily my job search journey has been quite eventful in a non-stressful way. One thing I have realized with the regulatory field is that if you have the experience, it can be easier for you to look for a job. And references play a significant role in the job search experience. For me, I did not have the experience, but I did my best to make connections on LinkedIn and reach out to them for co-op opportunities. It was quite challenging in the beginning, and you need to put in considerable effort. There will be rejections, ghosting and a lot more but you need to keep putting in the efforts. Luckily for me, I had a relative who worked in a medical device company, and I was able to secure a co-op in that company as a Quality and Regulatory Intern. I took this opportunity and learned as much as I could in the 6 months so it would be easier for me to look for a job after graduation. I put in my 100% and did get an offer from the same company after my graduation where I interned. However, I kept applying and reaching out to recruiters to see what else is available in the market and found another opportunity that I thought would be better for my career and joined another company which was multinational company. Since the job was getting monotonous and I wanted to explore more, I started applying for jobs and joined a mid-sized software as medical device company. Lastly, looking at my experience a recruiter reached out to me to join a start-up like company which had not more than 30 employees at the time. I was not looking to change but he was quite insistent, and I thought to myself that I should at least give it a chance. When I interviewed, I learned I was going to be the first Lead RA/QA Specialist reporting to the Director of Regulatory. I knew this was going to be a life-changing opportunity as the job responsibilities were exactly what I wanted to do and there was a lot of growth potential. I knew I had to join the company, so I did, and I love it so far. I have also been grateful for the managers I have got because they made me feel valued and appreciated and always gave me good opportunities. As for the number of applications, I don’t remember the exact number, but I might have applied to about 200 companies in total. Regulatory is a niche field and therefore the number of applications is less compared to tech fields. And my interview processes have been easier and mostly focused on personality/behavioral type rather than technical skills because you cannot check for technical skills in regulatory in an interview so much. They just test if you have the basic understanding of regulatory and quality and if you would be a good fit in the team and company. For me, the most stressful part was my visa experience since my H1B was not picked and I was getting tired and mentally exhausted of the entire lottery process. So, in my opinion, opportunities start knocking on your door once you gain experience. The most difficult part is getting into the industry the first time. It does take time to get a job you really like. It took me 2 jobs and 1 co-op (2.5 years) to finally land a job I really loved. Just make the most of each experience as it can be helpful in the future.

What would you tell your younger you regarding building your current career?

I don't have a lot to tell my younger self but these few things. 1. Develop and focus on soft skills as effective communication and collaboration is very important in the regulatory field. Regulatory Affairs is a marathon and not sprint. It is a continuous learning process and you Will learn the technical skills with time and experience. 2. Network. Network. Network. Build strong profesional networks. Networking provides insights, support, and potential career opportunities. 3. There are a lot of free resources related to regulatory available on the internet and fda.gov website is rich with valuable information. 4. It may be quite difficult and challenging to look for the first job, but keep trying and giving in your 100% becasue after you get the experience, its probably going to be a smooth ride.

Final thoughts & tips

To conclude, diving into regulatory affairs is like embarking on an exciting adventure. There is soo much to learn, explore and decide what you would be interested in. It's about blending your know-how with a hunger to keep learning. And the only thing to remember is ensuring that you are applying the accurate regulations and ensuring the product complies to those regulations. Picture regulations as a puzzle, and you're the expert solver. Challenges? They're just stepping stones to become even better. Every day, you're contributing to making healthcare safer and more innovative. So, stay curious, stay determined, and know that you're making a big difference. The road ahead is full of possibilities, and the world needs your skills. Keep rocking it!

Hiral Vora

Hiral Vora

Regulatory Affairs
Build Fellow
Open Avenues Foundation
Open Avenues Foundation

Hiral Vora is a Regulatory Affairs Fellow at Open Avenues Foundation, where she works with students leading projects in the Regulatory Field.

Hiral is a Lead Quality and Regulatory Affairs Specialist at Elucid Bioimaging, Inc. where she works on medical device submissions and ensuring compliance with the regulations.

Hiral has 4.5 years of experience as a regulatory specialist. Throughout her experience, she has participated in many audits for the company and communicated with regulatory authorities on various occasions.

She holds a degree in Regulatory Affairs.

A fun fact about Hiral: Her go-to comfort binge watch TV show is F.R.I.E.N.D.S and she has seen the entire series more than 7 times.

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