I am a dedicated Regulatory Affairs professional with a focus on the medical device sector, committed to ensuring that devices meet rigorous quality and safety standards. With 1.5 years of experience in medical device regulatory affairs, I have developed strong skills in preparing FDA regulatory submissions, managing QMS activities, and conducting in-depth research on international markets for regulatory compliance.Currently pursuing a Master's in Regulatory Affairs at Northeastern University, Boston. I am focused on deepening my knowledge of regulatory landscapes, ensuring product compliance, and staying updated with the latest industry regulations to foster a commitment to quality. I am passionate about leveraging both my academic knowledge and hands-on experience to drive regulatory excellence and foster innovation in the healthcare industry.I had the privilege of presenting my project, Global MedRegs, at the prestigious RAPS Convergence 2024, where it received positive feedback and appreciation from regulatory professionals, industry experts, and MedTech companies. Additionally, I served as a Student Ambassador throughout the conference, actively contributing to event planning, coordination, and networking initiatives, while supporting various activities to enhance the overall attendee experience.Skills:- International Standards like ISO 13485, ISO 14971, ISO 62304, and ISO 10993. - Proficient in Medical Device Regulations like the USFDA 21 CFR part 820, EUMDR 2017/745, IVDR 2017/746, IMDR (CDSCO), and Canada regulations. - Regulatory submissions for 510 (k) pathways, and Pre submissions for medical devices. - Expertise in FDA medical devices databases, and guidance documents, EUDAMED database and MDCG guidelines.- Possess knowledge of Internal and External Audit and MDSAP, FDA Registration & listing, and labeling requirements. - Drafting SOPs, Records, and publishing documents.- Implement CAPA, NCs, Risk Assessment, and identifying root cause analysis.- Microsoft Office Tools (Excel, PowerPoint, Word, Teams, Outlook.)
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Regulatory Affairs AssociateMg Health TechBoston, Ma, Us
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FounderGlobal Medregs Jan 2024 - PresentThe mission is to facilitate global market access for medical device manufacturers by offering a user-friendly interface that navigates through country-specific regulatory requirements, ultimately saving precious time and costs. -
Regulatory Affairs Intern (Experiential Learning Project)Devan Medtech Solutions Sep 2024 - Dec 2024Assist in the FDA pre-submission process by identifying predicates, and regulatory information, determining intended use, and developing regulatory strategies for new products, leveraging a strong understanding of FDA Q-Submission guidance and regulatory pathways.• Guide clients through the FDA pre-submission process, including preparing Pre-STAR and e-STAR templates, ensuring all regulatory requirements are met, and providing expertise on submission content, criteria, and facilitating effective preparation for meetings with the FDA.• Implement FDA medical device regulatory requirements and supported the regulatory approval processes globally for various clients. -
Qa & Ra InternNiramai Health Analytix Apr 2023 - Feb 2024Bengaluru, Karnataka, India• Prepared regulatory documents for the FDA submission process, focusing on obtaining 510(k) clearance for medical device products and ensuring compliance with the latest FDA guidance documents, ISO 62304, and maintained records as part of the products’ design history file (DHF).• Compiled requirements for global regulatory submissions by conducting extensive research on diverse international markets.• Led cross-functional team meetings with regulatory expertise and coordinated with different departments to achieve regulatory compliance.• Streamlined the EUDAMED registration process and performed a gap analysis to facilitate the transition from EUMDD to EUMDR.• Participated in external and internal quality system audits to assess compliance with QMS requirements, identified areas for improvement, implemented CAPAs to address non-conformances, and improved overall process efficiency, leading to the successful closure of audit findings.• Conducted root cause analysis to mitigate quality issues, and developed process documentation, including SOPs and work instructions.• Involved in risk assessments, failure mode, and effects analysis (FMEA) to identify and mitigate potential risks associated with the product -
Qa/Ra InternNesa Medtech Sep 2022 - Jan 2023Bengaluru, Karnataka, India• Acquired proficiency in ISO 13485, ISO 14971, ISO 10993, and IMDR (CDSCO) clauses and schedules, enhancing regulatory compliance knowledge.• Acquired comprehensive knowledge in medical device development, clinical research, literature survey, and technical intricacies.• Participated in Internal Audit and Management review meetings, emphasizing the significance of CAPA, ISO 13485, and FDA regulations.• Demonstrated responsibility for creating and maintaining templates and records crucial for the effective functioning of the Quality Management System (QMS). -
Qa/Ra InternMeditix Solutions Private Limited Jun 2022 - Jul 2022Bengaluru, Karnataka, India• Mastered software development life cycle skills in ISO 62304, Clause 5 and designed software specification documents for Class B devices.• Grasped the intricacies of the 4 levels of Quality Management System, emphasizing the significance of ISO 13485 standards, and gained insights into the regulatory processes.
Akash Kirani Education Details
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Regulatory Affairs
Frequently Asked Questions about Akash Kirani
What company does Akash Kirani work for?
Akash Kirani works for Mg Health Tech
What is Akash Kirani's role at the current company?
Akash Kirani's current role is Regulatory Affairs Associate.
What schools did Akash Kirani attend?
Akash Kirani attended Northeastern University, B. M. S. College Of Engineering.
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