Meet Our Senior Global Regulatory Associate
Sr. Global Regulatory Associate
Darshna brings 10 years of global medical device experience across a wide array of product types and manufacturers.
Darshna Lad is a Senior Global Regulatory Specialist with ten years of experience working with medical devices and IVDs, and has completed numerous global submissions across multiple regions, including LATAM, EMEA, ASIA, and the EU, encompassing a diverse range of devices across various classifications. As a Regulator, Darshna has always been driven and passionate about bringing devices into new countries, learning their regulations and processes in turn. This has allowed her to continually expand her knowledge and enhance her Regulatory Intelligence, an area of Regulatory she is committed to further developing. Throughout her career, Darshna has had the opportunity to work for several global companies, including Stryker, J&J, and ThermoFisher. These experiences have allowed her to learn and apply various regulatory strategies, as well as to put her knowledge of IVD and Medical device regulations into practice. She strongly believes that practical application of regulatory regulations with real products, rather than just theoretical study, is key to developing a deep understanding.
Education & Specialities
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BS in Chemical Engineering, AAS in Biotechnology
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Quality Engineering, Supplier Quality Engineering and Quality and Regulatory Management
Career Highlights
-Held positions of increasing responsibility in Quality Engineering, Supplier Quality Engineering and Quality and Regulatory Manager.
-Has worked on new product development teams, large scale automation projects, 510k submissions, FDA audit remediation and product recalls to name a few.