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Maham Ansari

Director, Regulatory Affairs

Maham Ansari

Director, Regulatory Affairs

Maham brings over a decade of medical device regulatory affairs experience to Synaptive Medical. Since joining Synaptive in 2016, she has implemented the foundation of Synaptive’s regulatory department, led several 510(k) clearances, successfully attained MDSAP certification and has played an instrumental role in expanding the company’s international footprint through introducing Synaptive’s product line in markets like Europe, Middle East and Asia Pacific. Prior to joining Synaptive, she has worked in both the UK and Canada for a variety of medical device and in vitro diagnostics start-ups as well as large organizations. She spent two and a half years as a senior regulatory consultant as part of UnitedHealth Group’s Regulatory Consulting division, where she supported a number of biotech and diagnostic companies in product development, clinical and regulatory submissions, and global regulatory strategies. While based in the UK, as part of the personalized medicine team at QIAGEN, a German molecular diagnostics leader, she played a leading role in the development and global regulatory approvals of novel and high-risk companion diagnostic products. Maham holds a Bachelor of Applied Science degree in Chemical Engineering from University of Toronto and a Master of Science in Bioscience Regulatory Affairs from the Johns Hopkins University. She also maintains a Regulatory Affairs Certification through the Regulatory Affairs Professionals Society, and serves on the Advisory Committee Board at the Northeastern University graduate programs in Regulatory Affairs.

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Maham Ansari

Director, Regulatory Affairs

Maham Ansari

Director, Regulatory Affairs

Maham brings over a decade of medical device regulatory affairs experience to Synaptive Medical. Since joining Synaptive in 2016, she has implemented the foundation of Synaptive’s regulatory department, led several 510(k) clearances, successfully attained MDSAP certification and has played an instrumental role in expanding the company’s international footprint through introducing Synaptive’s product line in markets like Europe, Middle East and Asia Pacific. Prior to joining Synaptive, she has worked in both the UK and Canada for a variety of medical device and in vitro diagnostics start-ups as well as large organizations. She spent two and a half years as a senior regulatory consultant as part of UnitedHealth Group’s Regulatory Consulting division, where she supported a number of biotech and diagnostic companies in product development, clinical and regulatory submissions, and global regulatory strategies. While based in the UK, as part of the personalized medicine team at QIAGEN, a German molecular diagnostics leader, she played a leading role in the development and global regulatory approvals of novel and high-risk companion diagnostic products. Maham holds a Bachelor of Applied Science degree in Chemical Engineering from University of Toronto and a Master of Science in Bioscience Regulatory Affairs from the Johns Hopkins University. She also maintains a Regulatory Affairs Certification through the Regulatory Affairs Professionals Society, and serves on the Advisory Committee Board at the Northeastern University graduate programs in Regulatory Affairs.

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