VAHIMA P
Regulatory Affairs / Quality Assurance Specialist / Senior Biomedical Engineer
Madurai,TN
Summary
Dedicated and results-oriented Bio-Medical Engineer with a specialization in regulatory affairs and complaints handling of medical device. Proven expertise in navigating complex regulatory landscapes, ensuring compliance with industry standards and regulations. Skilled in preparation and submission of technical documents as per regulatory agencies to the notified body, Navigates high stress situations and achieve goals on time and under budget. Possess a strong foundation in biomedical engineering principles, with a passion for improving healthcare outcomes through innovative solutions.
Overview
4
4
years of professional experience
10
10
Certificates
Work History
Regulatory Affairs Specialist
Quest Global Engineering
08.2024 - Current
- Directed the creation of the Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER), General Safety and Performance Requirements (GSPR), General Product Description (GPD), Declaration of Conformity (DOC), and User Specification document for the Surdial X Pro Hemodialysis Machine, ensuring full compliance with EU Medical Device Regulation (MDR).
- Conducted a thorough gap analysis for DIAMAX WOW, Surdial X, and DX devices, identifying non-conformities, and proposing strategic corrective actions to achieve regulatory compliance.
- Authored critical supporting documentation, including Document-Level Evaluation Reports, Software Risk Classification Documents, and Project Management Plans, achieving a 98% quality rating in client deliverables.
- Conducted literature reviews to support clinical evaluations and performance claims, leveraging scientific databases and resources, and also prepared literature review plans and literature search protocol documents.
- Developed, reviewed, and maintained cybersecurity-related documentation for hemodialysis machines in compliance with IEC 62304, ISO 14971, and FDA guidance.
- Assisted in critical translation activities, converting Japanese regulatory documents to English using DeepL and Microsoft 365 tools, ensuring linguistic and contextual accuracy.
- Facilitated training sessions for staff on compliance standards, regulations, and best practices.
Product Regulatory Analyst
HCL Healthcare Technology
02.2021 - 08.2024
- Spearheaded the regulatory journey for In Vitro Diagnostic (IVDR) products, managing pre-market submissions, and ensuring post-market surveillance activities adhered to regulations.
- Delivered a perfect record: achieved a 100% success rate for regulatory submissions, guaranteeing compliance with EU IVDR 2017/746 and MDR 2017/745 within timelines.
- Built a fortress of compliance: Developed and maintained regulatory documentation (STED, GSPR, APR, PER, SVR, CPR, and CER) to ensure adherence to standards.
- Proactive guardian of compliance: Identified regulatory risks and implemented QMS and clinical process improvements to ensure audit success.
- Streamlined complaint lifecycle: Managed the entire process of post-market surveillance activities, such as complaint intake, decision tree assessment, follow-up, closure, and clear communication with the client.
- Technical Expertise: Conducted literature reviews for IVD devices and possessed in-depth knowledge of relevant standards (ISO 13485, ISO 14971, ISO 15223, ISO 20916, IEC 62304).
- Authored a well-received white paper titled 'Global Challenges in Strengthening the Quality Assurance of IVD: Combating Counterfeit Medical Products.'
Education
MBA - Business Analytics
04.2001 -
Bachelor of Engineering - Biomedical Engineering
04.2001 -
HSC -
04.2001 -
SSLC -
04.2001 -
Skills
Regulatory compliance
Labeling and packaging compliance
Medical Device documents - Remediation, Gap analysis
Literature review
Performance evaluation
Clinical research
Quality assurance - Internal and external audits
Risk management
Trackwise tool
Cross-functional collaboration
Cybersecurity documentation
Salesforce tool
S-Max tool
DeepL tool
MS tools
Post-marketing surveillance - Complaints Handling
Timeline
Regulatory Affairs Specialist - Quest Global Engineering
08.2024 - Current
Product Regulatory Analyst - HCL Healthcare Technology
02.2021 - 08.2024
Amity University - MBA, Business Analytics
04.2001 -
P.S.N.A College of Engineering - Bachelor of Engineering, Biomedical Engineering
04.2001 -
C.E.O.A Matriculation Higher Secondary School - HSC,
04.2001 -
Saracens Matriculation School - SSLC,
04.2001 -
Languages
English
Bilingual or Proficient (C2)
Tamil
Bilingual or Proficient (C2)
Certification
Internal audit on Medical Device QMS - ISO 13485:2016, Udemy
INTERNSHIP
- Vadamalayan Hospital - Madurai, TN, India
- Aravind eye Hospital - Madurai, TN, India