Mohammed Kaja Navas Sherief M

WORK HISTORY

EDUCATION

ABOUT MOHAMMED KAJA NAVAS SHERIEF M

The journey to becoming a Regulatory Affairs Specialist in the medical device industry isn’t always linear. It requires a blend of precision, technical prowess, and a genuine passion for enhancing patient safety. That’s exactly the path I’ve walked over the past 4+ years. It all started with a passion for biomedical engineering, driven by the belief that technology could dramatically improve healthcare. After graduating with a Bachelor of Engineering, I dove headfirst into the world of quality assurance and regulatory affairs. I quickly found myself navigating complex frameworks like FDA regulations (21 CFR Part 820 & 803), ISO 13485, and EU MDR. It wasn’t just about ticking compliance boxes; it was about ensuring life-changing medical devices were as safe and effective as they could be. My first major challenge came at HCL Technologies. Here, I took the reins on global complaints processing for a range of medical devices. Assessing reportability, crafting meticulous Medical Device Reports (MDRs), conducting root cause analyses – this was my playground. I soon became the go-to expert for Class device PSURs, learning to balance the demands of regulatory compliance with the urgency of CAPA implementations. Fast forward to my current role at Cyient, where I’m managing complaints for diabetic equipment, particularly insulin pumps. My days are filled with navigating SmartSolve, verifying design documents, and ensuring risk management practices are airtight. Leading DHF remediation and authoring MDRs isn\'t just work to me; it\'s a commitment to patient safety and regulatory excellence. My career is underpinned by a unique blend of skills – from technical writing to risk assessment, from hands-on software expertise with SmartSolve and Trackwise to liaising with cross-functional teams and regulatory bodies. I’ve found that being adaptable and proactive is key to thriving in this fast-paced industry. Ultimately, my goal is to continue championing regulatory compliance and quality management. By leveraging my technical knowledge and hands-on experience, I aim to drive the safe, effective use of medical devices globally. Let’s connect if you’re passionate about quality assurance, regulatory affairs, or advancing healthcare technology. What do you believe is the most pressing challenge facing the medical device industry today?