Martin's expedition began in 1979, immersing himself in the realm of legal documents related to medical devices in the UK. From a design and development engineer to a researcher unraveling the mysteries of the brain's response to stimuli, Martin's career unfolded through diverse roles in regulating electricity meters, collaborations with tech giants like Microsoft and Oracle, and a return to the realm of pharmaceuticals and medical devices. His extensive repertoire includes building pharmaceutical factories, steering a pharmaceutical company for eight years, and contributing to the foundational development of quality management systems.
The turning point in Martin's odyssey emerged during a career transition triggered by a company merger. Embracing the challenges, he ventured into consulting, where he thrived on projects involving MDR CE marks, IVDR CE quality management systems, FDA submissions, and more. His expertise shines when companies face regulatory hurdles, turning to him for assistance in rectifying rejected submissions or navigating the intricacies of the submission process.
"While most of the content is usually there, occasionally some pieces are missing. The only way to find out is by actively working through the entire remediation process, from the beginning to the end of creating the necessary regulatory submission file and documents."
Still active in consulting, Martin wears the hat of the Head of Regulatory at Gerresheimer, a company renowned for its pharmaceutical packaging solutions. At the Advanced Technologies Group, he oversees regulatory affairs for advanced technologies while concurrently managing consulting projects. Reflecting on his roles, Martin emphasizes the essence of regulatory affairs, stating, "Regulatory is about finding the way."
Martin's journey mirrors the highs and lows of regulatory challenges, with the most rewarding aspect being the contribution to causes and the execution of challenging projects. The thrill of bringing a project back on track, especially when it has veered off course, is his driving force. Yet, he acknowledges the most challenging aspect – people. Balancing strict laws and regulations with the technicalities of product development proves daunting, particularly when conveying the importance of patient safety to those engrossed in engineering intricacies.
"I am driven by contribution and execution. When I can contribute to a cause and I can help someone, then that's very motivating. I invest in challenging situations - when everything is falling apart and the project has gone off the rails, that's where I'm best. It's an execution task to stand back and put the pieces together."
Martin envisions a harmonized global regulatory landscape and advocates for a standardized approach akin to the International Medical Device Regulators' forum (IMDRF) model. Such an approach, he believes, would streamline the certification process, providing a more efficient regulatory framework.
To aspiring regulatory professionals, Martin imparts wisdom gained from his journey, emphasizing the significance of hands-on experience, niche specialization, and continuous adaptation to industry changes. His extensive journey serves as a testament to the industry's challenges, rewards, and the perpetual pursuit of global regulatory harmonization. In the ever-evolving terrain of regulatory affairs, luminaries like Martin King continue to lead the charge, navigating complex waters to ensure the safety and efficacy of medical devices worldwide.
Thank you Martin for such an insightful conversation, your immense knowledge and love for what you do is evident!
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