Mansi Jain
Regulatory Affairs
Pune
Summary
Regulatory Affairs Specialist with 7+ years of experience in medical devices, specializing in EU MDR, US FDA, and global regulatory submissions. Proven expertise in preparing Technical Files, STED, CER, and GSPR documentation, along with strong knowledge of regulations and portal submissions.
Experienced in QMS implementation (ISO 13485, QMSR, MDSAP), risk management (ISO 14971), and SaMD compliance (IEC 62304). Demonstrated ability to lead regulatory strategy, manage audits, and collaborate cross-functionally to ensure compliance while supporting business objectives and timely market access.
Overview
7
7
years of professional experience
4
4
Certificates
Work History
Senior Engineer
Tata Elxsi
Pune
10.2023 - Current
- Lead preparation and review of regulatory submissions for EU MDR and global markets, ensuring compliance with applicable regulatory frameworks.
- Develop and maintain Technical Documentation (Technical Files, STED, GSPR) for Class II/III medical devices
- Support SaMD regulatory activities, including software lifecycle documentation aligned with IEC 62304
- Ensure alignment of QMS (ISO 13485, QMSR) with regulatory submissions and product lifecycle requirements
- Handle regulatory change management, assessing impact on submissions and product compliance
- Collaborate with cross-functional teams (R&D, QA, Clinical) to ensure regulatory readiness.
Associate
Freyr Solutions
Hyderabad
09.2021 - 09.2023
- Managed 15+ global regulatory submissions across EU, US, and ROW markets
- Prepared and reviewed CER, CEP, and literature reviews in compliance with EU MDR
- Developed GSPR checklists, STED dossiers, and regulatory documentation for multiple therapeutic areas
- Supported client regulatory strategy development for market entry and product lifecycle management
- Responded to Notified Body and regulatory authority queries with structured, evidence-based documentation
- Ensured compliance with post-market requirements, including vigilance and regulatory updates.
Senior Engineer
Syrma Johari Digital Healthcare Pvt. Ltd
Jodhpur
03.2019 - 08.2021
- Supported design and development activities, ensuring compliance with ISO 13485 and design control requirements
- Performed verification & validation (IQ, OQ, PQ) for medical devices
- Led CAPA investigations, root cause analysis, and effectiveness checks
- Managed change control processes, ensuring regulatory and risk alignment
- Participated in internal and external audits, ensuring documentation readiness and compliance
- Conducted equipment calibration and process validation activities
Education
Bachelor of Science - Electronics And Communications Engineering
Govt. Women Engineering College
Ajmer, India 04.2001 -
Skills
Global Regulatory Submissions (EU MDR, FDA, ROW)
Technical Documentation (STED, Technical File, CER, GSPR)
QMS: ISO 13485, FDA QMSR, MDSAP
Risk Management (ISO 14971)
SaMD & Software Lifecycle (IEC 62304)
CAPA, RCA, Change Control
Clinical Evaluation & Literature Review
Post-Market Surveillance (PMS, Vigilance)
Audit Management (Internal, External, NB, FDA)
Cross-functional Stakeholder Management
TrackWise software
SAP Business One
QMS Software (Confluence)
Team leadership
Certification
Practical Regulatory Affairs 2020 - US FDA Medical Devices
Timeline
Mini Course MDR
12-2023
Senior Engineer
Tata Elxsi
10.2023 - Current
Practical Regulatory Affairs 2020 - US FDA Medical Devices
05-2022
Associate
Freyr Solutions
09.2021 - 09.2023
ISO 14971:2019 Risk management for medical devices
10-2020
SIX SIGMA PRINCIPLE
09-2020
Senior Engineer
Syrma Johari Digital Healthcare Pvt. Ltd
03.2019 - 08.2021
Bachelor of Science - Electronics And Communications Engineering
Govt. Women Engineering College
04.2001 -