Ragini Chawde

Regulatory Affairs | Medical Devices | EU MDR & IVDR Compliance | ISO 13485 | Clinical Evaluation & Risk Management

Role: Sr Regulatory Executive at Maven Profcon Services LLP
Location: Pune Division, MH, IN
LinkedIn followers: 500 followers

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Experience

Sr Regulatory Executive
Maven Profcon Services LLP
Oct 2025 — Present

Education

Smt Kishoritai Bhoyar College of Pharmacy, Kamptee
Bachelor of Pharmacy - BPharm, Pharma
2017 — 2021
Poona College of Pharmacy, Pune
Bhartiya Vidyapeeth Deemed University, Master's of Pharmacy,Drug Regulatory Affairs
2021 — 2023

Contact information

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Work email
•••••@mavenprofserv.com
Personal email
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Current company

Maven Profcon Services LLP

Business Consulting and Services · 93 employees · Founded 2016 · Ahmedabad, Gujarat, India

Maven Profcon Services LLP is a regulatory consulting firm specializing in global medical device and IVD compliance. We help manufacturers navigate complex regulatory frameworks and successfully bring their products to international markets. Our team works closely with medical device companies across the entire regulatory lifecycle—from documentation, risk management, and clinical evaluation to regulatory approvals and post‑market compliance. Maven combines deep regulatory expertise with a practical understanding of industry requirements to simplify complex compliance pathways. Our areas of expertise include EU MDR and CE Marking, US FDA 510(k), UKCA certification, ISO 13485 quality management systems, MDSAP, and global market entry strategies for medical device and IVD manufacturers. We also support organizations with regulatory documentation such as Clinical Evaluation Reports (CER), Risk Management Files (RMF), Post‑Market Surveillance (PMS), PSUR, and PMCF activities. Over the years, Maven has partnered with more than 300 organizations worldwide and has supported a significant proportion of orthopedic implant manufacturers in India in achieving regulatory compliance and international market access. With a growing team of regulatory experts and consultants, Maven is committed to helping organizations build strong compliance foundations while ensuring that safe and effective medical devices reach global markets.

mavenprofserv.com

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Experience

Sr Regulatory Executive

Education

Smt Kishoritai Bhoyar College of Pharmacy, Kamptee

Poona College of Pharmacy, Pune

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