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When you look at Attrayee Chakraborty’s eight-page resume, you may wonder what you’ve been doing with your time.

Chakraborty, who goes by Atty, has a depth of experience that would be impressive for someone with decades in the industry—yet she graduated from college just four years ago.

She’s a certified ISO 13485:2016 medical device auditor who has published multiple papers and feature articles, helped products receive FDA clearance, resolved long-standing quality issues, reviewed a course syllabus, and judged other papers. As of this writing, she has spoken at more than 20 events—though that number will likely climb by the time you read this.

It’s no wonder a previous colleague described her as a genius.

Despite being an intern in a prior role, she contributed to a company’s work—she found the internship by reaching out to the CEO on LinkedIn—and impressed her colleagues. When interns are expected to just not break anything, she made real contributions.

At another previous internship, she was instrumental in the FDA clearance of a Class II medical device. She helped improve the company’s quality management system, and resolved long-pending corrective and preventive actions. She’s been described as tenacious, hard-working, and knowledgeable.

Quality is honored to name Attrayee Chakraborty as our 2025 Quality Rookie of the Year.

Journey to Quality

She Came, She Saw, She Started a Career

Meet our 2025 Quality Rookie of the Year, Attrayee Chakraborty. She is a quality professional in the medical field with a background in biotechnology and expertise in Artificial Intelligence (AI).

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As a kid, she wanted to be an author. And with so many published papers, it seems she is accomplishing this as well. During college, she was good at science, and also enjoyed being part of the debating society. She graduated with a degree in biotechnology, ranked number three at her university and 23 for the entire country of India.

Originally interested in research, after working in the field she found she enjoyed working with teams and didn’t want to work in a lab for her entire career. She came across a startup incubator and started talking to the founders about quality. She realized it was a good fit for her skills.

She decided to pivot and continue her education. She came to the U.S. for higher education and graduated with a master’s degree in Regulatory Affairs Drugs, Biologics and Medical Devices—with 3.9 GPA—from Northeastern University.

She said it can be difficult to stand out, but she definitely has stood out so far. Her current and former colleagues all say she has made her mark after such a short time in the field. It’s a loss for biotech research, but the medical device field is lucky to have her. Chakraborty wants to help quality professionals use AI in their work.

She believes in continuous improvement and says people shouldn’t underestimate the importance of quality.

“Quality is something which people don’t see every day but it’s something that makes or breaks your product,” she says.

One of her favorite aspects of quality is the user experience. “There’s so much we can improve,” she says.

She’s particularly interested in seeing how users interact with quality software, emerging technology, and the compliance overlap between medical devices and pharmaceuticals.

Even as an early career professional, it is possible to assert yourself and implement your ideas. She started a collaborative system with HR software  to recognize colleagues on their work. “Everyone loves to be recognized if they do a good job,” she says.

Regulation and Communication

Apurva Kushare, regulatory affairs specialist lead, RegDesk Inc., met Chakraborty at a medical conference and they later worked together for one semester. “It was great. She is a genius. She has a profound knowledge about the regulatory updates, especially involving AI devices,” Kushare says.

She said her knowledge, along with her ability to communicate and collaborate really make her stand out. If you’re looking to follow her lead, Kushare advises others to be more proactive and learn as much as you can.

In her nomination letter, Kushare wrote, “Attrayee’s in-depth analysis and reporting on artificial intelligence and cybersecurity regulations for medical devices have been indispensable. By providing comprehensive regulatory intelligence for 20 nations, Attrayee has kept our organization at the forefront of international regulatory trends and enabled us to anticipate future challenges and opportunities in this rapidly evolving domain.”

Smart and Tenacious

Elliot Franz, founder of Uncommon Innovation, first met Chakraborty when he was interning for a company that manufactures a medical device that uses a virtual reality (VR) headset to perform certain vision exams. He was working an independent consultant to help the company achieve a certification to expand their market abroad. “Atty joined us for a three-month internship, and during those months I was extremely surprised by how quickly she grasped quality principles and was able to apply them. She absorbed everything at an exponential rate, understanding the interrelationships between various aspects of quality much faster than most people I've worked with.”

“If I had to describe Atty in one word, it would be tenacious. Her dedication and drive lead me to believe that she will be a future thought leader in quality, and I am excited to see what she will achieve. I am confident that Atty will continue to excel and make significant contributions to the medical device industry and the patients it serves.”

That leadership continues today. As her current manager stated, “I have had the pleasure of witnessing her dedication, expertise, and leadership firsthand in various QMS elements.”

Quality Philosophy

Lacey Harbour, a member of the Strategic Committee for the AI-Global Health Initiative, an FDA Collaborative Community, recognized Chakraborty’s commitment to the field in her nomination letter. “One of Atty’s most remarkable qualities is her relentless pursuit of excellence. She is always willing to go the extra mile, whether it involves conducting thorough research, collaborating with cross-functional teams, or presenting her findings to stakeholders.”

“Her passion for leveraging AI to enhance healthcare outcomes is matched by her strong ethical considerations, ensuring that safety and efficacy are never compromised.”

While compromises may be warranted in some cases, she would never give in with the health of a patient at stake. Thinking of where your product will go is always a priority.

If someone thinks you’re overdoing it on quality or being too compliant, you know that the patient’s well-being is the reason not to back down, Chakraborty says.

"Whatever happens it’s about the patient at the end."

NOTE: The opinions expressed on this website are solely those of the interviewee(s) and do not necessarily reflect the views of any organization, company or entity the interviewee(s) are associated with.

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