Sonali Dewan Email & Phone Number

Accomplished Sr. Regulatory Affairs Leader with Chemical Engineering Degree and over 17 years of comprehensive experience and expertise developing global regulatory strategies and submissions for complex medical devices, including SaMD, SiMD, remote patient monitoring, clinical decision software, active implantable cardiovascular devices, neurovascular and combination products. Skilled in providing regulatory guidance, steering cross-functional teams, leading Health Authority interactions, and ensuring adherence to relevant standards and regulations. Passion for regulatory leadership to drive innovative products from development through commercialization.Core Competencies:Regulatory Strategy Development: Excel in crafting regulatory strategies tailored to a wide array of medical devices and combination products, spanning Software (SaMD), (SiMD), Neurovascular, Cardiovascular, Electro-mechanical devices, Cell Therapies, Drug Delivery Devices, Digital Health Technologies, Remote Patient Monitoring, and Clinical Decision Software. Expertise in providing strategic insights and technical guidance to cross-functional teams to navigate development towards regulatory compliance. Skilled at efficiently addressing Regulatory Agency inquiries and information requests through successful negotiation, resulting in product approvals aligned with business objectives.Submission and Technical Expertise: Skilled in meticulously preparing regulatory submissions and gaining approvals/clearance for the US, Canada, and EU markets, encompassing a wide array of submissions including PMA, PMA-S, 510(k), de Novo, 513(g) classification requests, IDE/IDE-S, Annual Reports, EU MDR CE Mark submissions, Design Dossiers, CE Tech Files, CTA/ITA, preIND, INDa, and INDs. Experienced in 21 CFR 820, ISO 13485, GCP, GLP, GMP, EU MDR (EU 2017/745), IEC 62304, ISO 14971, IEC 62366, ISO 10993, and IEC 60601.Communication and Presentation Skills: Skilled in communicating regulatory strategies and requirements with clarity and precision, essential for effective collaboration across diverse teams, regulatory bodies, and stakeholders. Demonstrated expertise in delivering compelling presentations and reports to executive audiences, offering strategic recommendations for regulatory pathways and securing endorsement for the chosen direction.Leadership Experience: Proven leadership experience in recruiting, managing, and mentoring professionals. Proficient in leading cross-functional project teams to ensure regulatory adherence and the successful progression of product development initiatives.