Eashan Mahajan
Summary
Regulatory Affairs and R&D Engineer with 4+ years of experience supporting global Medical Device regulatory strategy for Class I and Class II devices. Proven expertise in 510(k) and De Novo submission leadership, EU MDR Technical Documentation, Design Control Compliance, CAPA ownership, and Post-Market Surveillance. Demonstrated ability to lead cross-functional teams, interface with global regulatory bodies, and ensure audit-ready quality systems across the full product lifecycle. Experienced in US FDA, EU MDR, UKCA (MHRA), and international market registrations.
Overview
4
4
years of professional experience
6
6
Certifications
Work History
REGULATORY AFFAIRS SPECIALIST
QNQ Design and Development Pvt. Ltd. (Consure Medical)
New Delhi
09.2021 - Current
- Led end-to-end regulatory submissions for Class I and Class II medical devices, including 510(k), De Novo, and EU MDR Technical Documentation, ensuring compliance with FDA 21 CFR 820 and EU MDR 2017/745.
- Served as the regulatory lead for the successful transition of a legacy Class IIa device from EU MDD (93/42/EEC) to EU MDR, including gap assessment, remediation, and Notified Body coordination.
- Developed, reviewed, and maintained Design History Files (DHF), Device Master Records (DMR), and Technical Documentation, achieving audit outcomes with no major nonconformities.
- Acted as the primary regulatory interface with Notified Bodies, Authorized Representatives, and international distributors to support approvals across the US, EU, UK, Latin America, Southeast Asia, and the Middle East.
- Ensured compliance with ISO 13485, ISO 14971, ISO 10993, IEC 60601, IEC 62304, IEC 62366, and cybersecurity requirements throughout the product lifecycle.
- Owned medical device labeling strategy, including symbols per ISO 15223-1, IFU compliance (ISO 20417), and UDI implementation for FDA and EU MDR.
- Led and supported FDA QSIT, ISO, and CE audits, demonstrating regulatory decision-making accountability, and inspection readiness.
- Owned and executed CAPA and Nonconformance (NCR) processes, performing root cause analysis, and driving systemic quality improvements.
- Conducted post-market surveillance activities, including clinical evaluation support, PSUR preparation, vigilance reporting, and ongoing risk-benefit analysis.
- Collaborated cross-functionally with R&D, Quality, Manufacturing, and Clinical and Marketing teams to align regulatory strategy with business and product objectives.
R&D ENGINEER
QNQ Design and Development Pvt. Ltd. (Consure Medical)
New Delhi
09.2021 - Current
- Led design and development activities for Class I and II medical devices from concept through commercialization, ensuring compliance with regulatory and design control requirements.
- Owned Design Control processes, including user needs, design inputs/outputs, design reviews, traceability matrices, and verification & validation planning.
- Designed and validated hardware and software components for medical and software-in-a-medical-device (SiMD) products in compliance with IEC 60601 and IEC 62304.
- Executed Verification and Validation (V&V) activities aligned with FDA, EU MDR, and IEC standards, including usability engineering per IEC 62366-1.
- Conducted Process Validation activities (IQ, OQ, PQ) in alignment with ISO 13485 and FDA 21 CFR 820 requirements to ensure manufacturing process robustness and regulatory compliance.
- Conducted Biocompatibility assessments (ISO 10993) for invasive and non-invasive devices.
- Performed Root Cause Analysis (RCA) and implemented design improvements based on testing, complaints, and field feedback.
- Supported manufacturing transfer, including engineering drawings, production fixtures, and process validation inputs.
Education
Master of Science - Biomedical Engineering
University At Buffalo
Buffalo, New York08-2020
Bachelor of Science - Biomedical Engineering
D.Y. Patil University
Navi Mumbai, Maharashtra07-2017
Skills
- Regulatory strategy and submission leadership
- 510(k) and De Novo submissions (FDA)
- EU MDR (2017/745) technical documentation and MDD-MDR transition
- Global market registration (US, EU, UK, LATAM, SEA, Middle East)
- Design control compliance (21 CFR 820, ISO 13485)
- CAPA and Non-Conformance ownership audit readiness and regulatory inspections (FDA QSIT, ISO, CE)
- Risk Management (ISO 14971, FMEA)
- Post-Market Surveillance (PMS, PSUR, Vigilance)
- Labeling, UDI, and Regulatory Intelligence
Certification
Medical Device Regulation (EU MDR 2017/745)
Timeline
REGULATORY AFFAIRS SPECIALIST
QNQ Design and Development Pvt. Ltd. (Consure Medical)
09.2021 - Current
R&D ENGINEER
QNQ Design and Development Pvt. Ltd. (Consure Medical)
09.2021 - Current
Master of Science - Biomedical Engineering
University At Buffalo
Bachelor of Science - Biomedical Engineering
D.Y. Patil University