I had the opportunity to have a virtual coffee chat with Carla Konzel, and she is truly impressive! From her background as a microbiologist to her current role as a Senior Manager in the Global Regulatory Department at STERIS Corporation, Carla shared valuable insights about leadership, continuous learning, and the ever-changing world of regulatory affairs. I gained valuable knowledge about her problem-solving approach and perspective on regulatory professionals' main challenges today. Carla's experience and wisdom make her stand out in regulatory affairs as a Rockstar.
Carla's journey into the world of regulatory affairs began with her background as a microbiologist conducting tissue culture research. Her transition to quality management at Becton Dickinson opened the doors for her to venture into the regulatory department. During this period, regulatory and quality departments worked hand in hand to guarantee compliance with product laws and country-specific regulations. As Carla's career progressed, she took on responsibilities in acquisitions at Becton Dickinson, which deepened her understanding of regulations, notably ISO 9001 and ISO 13485 standards. This invaluable experience expanded her knowledge and established a strong foundation in regulatory affairs.
As a leader in her current company, Carla highlights the significance of soft and technical skills in her leadership role. One of her core principles is leading by example, believing leaders should never ask their team to do something they wouldn't do themselves. Carla's approach also includes being a good listener and understanding the needs of her team, enabling her to provide relevant information efficiently.
In addition to really understanding and listening to your team, Carla highlighted several technical skills essential for regulatory leaders. These include financial acumen, budget management, and a background in science, often complemented by advanced degrees or certifications. Equipped with an MBA, she mentioned that in the first company she was with, "if you couldn't manage a budget, then you weren't in management [...] which is something people often do not understand." Moreover, a comprehensive understanding of various regulations, such as 21 CFR for the FDA, is crucial in ensuring compliance.
Carla finds great joy in supporting her colleagues in accomplishing their tasks and reaching their goals. She derives immense satisfaction from meticulously preparing for global audits and achieving favorable outcomes. However, she recognizes that the continuous learning process can pose challenges. The ever-changing nature of regulations necessitates adaptability and a steadfast commitment to ongoing education.
"Sometimes you have to think outside the box about how you're going to try to accomplish your goal. [...] The challenging part is the continuous learning process, but I also find that rewarding as well. I don't see that as a downside. I see it as an opportunity to be a stronger regulatory professional."
Carla's advice to her younger self, as well as anyone considering a career in regulatory affairs, is to be proactive in "investing in yourself" by actively seeking self-development opportunities beyond your current role. She encourages individuals to carve out their own path instead of relying solely on employers for growth and learning. Carla emphasizes the importance of pursuing a career that brings joy and fulfillment.
"Invest in yourself [...], you are always worth it. If you don't know what you want to do when you grow up, go talk to people. Do your research and reach out to people, ask them to chat. If you want to enjoy your life and want work to be fun, then pick an area that you love, because life's too short."
Her career path may have led her to regulatory affairs, but her innate drive for continuous process improvement has remained constant. She genuinely desires to enhance processes, whether within her role in regulatory affairs or volunteering with emergency response teams. Carla's colour-coded system for organizing her family's life is a testament to her dedication to efficiency and simplicity: "Everybody had a colour, and they didn't know anything different."
She describes herself as a solution seeker, which undoubtedly serves her well in regulatory affairs. Her ability to identify improvement areas and seek solutions is a key factor in her success. This approach not only benefits her professional endeavours but also trickles down to her personal life, where she emphasizes the importance of clutter-free and streamlined living.
Carla identified the lack of global collaboration on a unified standard when asked about the biggest threat to regulatory affairs professionals. She used the example of the MDSAP (Medical Device Single Audit Program) as a successful pilot program, demonstrating the potential benefits of unified standards. However, she highlights the challenge of countries adding specific regulations, potentially complicating the process. She mentioned the importance of simplifying and streamlining regulatory processes globally. She believes that a singular system for product distribution and acceptance would lead to more readily available healthcare products worldwide. Carla advocates for continued collaboration through forums, regulatory conferences, and committees working on ISO standards to achieve this goal.
Finally, the Regulatory Rockstar movement emphasizes the importance of harnessing the power of Artificial Intelligence and Machine Learning. Carla expressed enthusiasm about the potential of AI in regulatory affairs. She has already explored its applications in research, clinical writing, and documentation for technical file submissions. While AI can accelerate access to information, she believes it can "never replace the human factor." Human interpretation, context, and critical thinking remain invaluable in regulatory decision-making.
Regulatory affairs professionals play a vital role in the healthcare industry by facilitating the approval of life-saving innovations, contributing to the advancement of healthcare, and ultimately improving patient outcomes. Their expertise in navigating complex regulatory environments ensures that medical devices and treatments adhere to stringent safety and efficacy requirements.
Ultimately, Carla Konzel's extensive experience and knowledge in regulatory affairs make her a true powerhouse in the field. Her remarkable journey and valuable insights serve as a guiding light for professionals navigating the intricate world of regulatory affairs.
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