Shikha’s entry into Regulatory Affairs was unplanned, a common experience for many professionals in this field. “I did my undergraduate degree in pharmacy,” she shares, “and I was initially focused on clinical research. However, an unexpected opportunity in Regulatory Affairs piqued my interest.”
This serendipitous shift led her to discover RA professionals' pivotal role in bringing innovative medical devices to market. “When I learned more about the responsibilities involved, I realized how essential RA is in ensuring patient safety and advancing healthcare technology.”
Regulatory Affairs is a multidisciplinary field that requires collaboration across various departments, including R&D, marketing, and compliance. Shikha emphasizes, “RA is not just about regulatory submissions. It’s about working with diverse teams to ensure a product meets global regulatory standards and truly benefits patients.”
Shikha’s career demonstrates the importance of staying current with industry developments. “The most rewarding aspect of my job is contributing to the global healthcare landscape by introducing advanced technologies. However, this also comes with challenges, especially as regulations and technologies constantly evolve.”
Despite its rewards, Regulatory Affairs has its challenges. One significant issue Shikha highlights is the outdated nature of some regulatory frameworks. This gap creates complexities for companies as they strive to meet regulatory requirements while innovating. Shikha advocates modernizing regulatory guidelines to better align with today’s MedTech advancements.
“Many of the regulations we work with are decades old, often lacking clarity on how to apply them to contemporary medical devices.”
As the industry embraces digital transformation, the role of artificial intelligence (AI) in Regulatory Affairs has become a hot topic. Shikha is cautiously optimistic, acknowledging that AI can streamline specific tasks but cannot replace human expertise. “AI has its place in RA, especially for automating routine tasks, but human oversight is crucial for interpreting complex regulatory requirements.”
She views AI as a valuable tool that can enhance efficiency, particularly in managing data and document workflows, but stresses the importance of maintaining human judgment in decision-making processes.
Global regulatory harmonization remains a critical goal for the MedTech industry. Shikha notes that while progress is being made, mainly through initiatives like the Medical Device Single Audit Program (MDSAP), there is still much work to be done. “We’re seeing some alignment in regulatory practices among key markets, but achieving full global harmonization will require ongoing collaboration and refinement.”
Shikha emphasizes the need for consistency in regulatory guidelines across different regions to reduce the burden on companies and improve patient access to new technologies.
When asked about the skills that are essential for success in Regulatory Affairs, Shikha highlights the importance of collaboration and clear communication. “Collaboration is crucial, not only within your company but also with regulatory bodies. Clear and concise communication can significantly impact the speed and success of regulatory approvals.”
“Staying informed about the latest regulations, industry trends, and emerging technologies is vital. Engaging with professional societies like the Regulatory Affairs Professionals Society (RAPS) is a great way to network and stay current.”
Shikha’s involvement with RAPS has been particularly beneficial. “I initially engaged with RAPS to prepare for the Regulatory Affairs Certification (RAC) exam. Over time, I started volunteering, authoring chapters in their books, and contributing to exam content. These activities not only enhanced my knowledge but also expanded my professional network.”
While Shikha is currently an individual contributor, she also manages contractors, providing her with valuable leadership experience. She believes that effective leadership in RA requires a balance of emotional intelligence and technical expertise. “A good leader must be empathetic and clear in communication while trusting their team to deliver.”
Shikha’s advice for newcomers to the field is straightforward: “Regulatory Affairs requires a commitment to learning, collaboration, and clear communication. Stay curious, be proactive in seeking mentorship, and always strive to enhance your skills.”
Outside of her career, Shikha enjoys hiking and is an avid movie enthusiast. “I love watching films from around the world, regardless of language. It’s a great way to relax and gain cultural insights.”
Her passion for learning extends beyond her professional life, as she is currently improving her Spanish, reflecting the curiosity and drive that contribute to her success in Regulatory Affairs.
Being successful in Regulatory Affairs is like having a deep love for global travel. Just as a seasoned traveler navigates diverse cultures, languages, and landscapes with curiosity and adaptability, an RA professional must skillfully maneuver through the complex and varied regulatory landscapes of different countries. In the same way that a traveler prepares for a journey by researching destinations, packing appropriately, and learning key phrases in a new language, an RA specialist prepares by studying the ever-changing regulations, understanding local nuances, and communicating clearly with regulatory bodies. Both require a passion for continuous learning, an appreciation for detail, and the ability to adapt to unexpected challenges. And, just as Shikha finds joy in exploring new places and cultures, her success as an RA professional fulfills her by ensuring that innovative medical devices reach patients worldwide!
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