Sarvesh Bhoomkar
Aspiring Regulatory Affairs Specialist opportunities | AI/ML Medical Device Compliance & FDA Submissions | Bridging Innovation with Global Regulatory Strategy
- Role
- Regulatory Affairs Intern at Lexim Ai
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Sarvesh Bhoomkar
As a dedicated Master’s candidate in Regulatory Affairs at Northeastern University, I specialize in ensuring compliance for healthcare innovations, including AI-driven medical devices, biologics, and pharmaceuticals. My expertise spans FDA/EMA submissions (IND, NDA, 510(k)), pharmacovigilance operations, and global regulatory strategy, with a focus on bridging technical advancements with ethical and efficient compliance. Key Contributions: Developed regulatory roadmaps for AI/ML-based SaMD tools at Purcell AI, resolving TGA compliance challenges and reducing approval timelines by 30%. Processed 1,200+ Individual Case Safety Reports (ICSRs) at Cognizant, ensuring 100% adherence to FDA, EMA, and ICH guidelines for drug safety and adverse event reporting. Authored academic projects including an Investigational New Drug (IND) submission strategy and risk-benefit frameworks aligned with 21 CFR 312 and GCP standards. Skills & Compliance Expertise: Regulatory Submissions: IND, NDA, 510(k), eCTD, and SaMD compliance. Guidelines: FDA 21 CFR, ICH, GCP, EU MDR, and ISO 13485. Tools: Argus, ArisG, SharePoint, and Power BI for data-driven decision-making. I excel in collaborative settings, combining meticulous attention to detail with the ability to deliver results under pressure. My goal is to contribute to a forward-thinking organization in healthcare, biopharmaceuticals, or medical devices, where I can leverage my regulatory knowledge to accelerate safe and impactful innovations. Let’s connect to discuss regulatory strategy, AI in healthcare, or opportunities in biopharma/medical devices!#RegulatoryAffairs #SaMD #FDACompliance
Experience
Regulatory Affairs Intern
Apr 2025 — Present · Cupertino, CA, US
Education
Shree Champavati Junior college
Higher secondary education
2015 — 2017
Sanskar Vidyalay Beed
Primary and Secondary Education
2005 — 2015
Sinhgad Technical Education Societys Sinhgad Institute of Pharmacy, Pune Mumbai Bypass Highway, Narhe Ambegaon,Dist.Pune 41
Bachelor of Pharmacy - BPharm
2017 — 2021
Northeastern University
MS in Regulatory affairs
2023 — 2025
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