Technical Lead - Medical Device Labeling
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With over a decade in the healthcare and MedTech space, I bring expertise in regulatory compliance, medical device labeling, and quality systems. At HCLTech, I lead global regulatory affairs initiatives, ensuring adherence to MDR 2017/745, ISO 13485, and FDA regulations. My work focuses on creating and revising technical documentation, managing artwork, and overseeing change control processes to support production transfers and maintain compliance.
I specialize in collaborating across teams to streamline processes and enhance patient safety through meticulous documentation and risk management. Proficient in tools like Adobe Acrobat Pro and Agile PLM, I empower teams to deliver high-quality outcomes. Committed to advancing healthcare technology, I thrive in dynamic environments where compliance and innovation intersect.
B.E Biomedical Engineering
