Sowmya Senthil
Regulatory Affairs Specialist
Kelambakkam
Summary
A competent professional with 7.2 years of experience, striving for a better and safe healthcare industry by playing a suitable role in the Quality and Regulatory department of Medical Devices. Proficient in MDR/IVDR regulations, standards, and best practices. Analytical and detail-oriented professional focused on making sure medical devices meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.
Overview
8
8
years of professional experience
4
4
years of post-secondary education
2
2
Languages
Work History
Regulatory Affairs Specialist
Upshot Engineering LLP
CHENNAI
09.2024 - Current
- Prepared and submitted regulatory file applications and supporting documentation relating to EU MDR 2017/745 for Medical devices.
- Demonstrated expertise in regulatory compliance, data synthesis, and stakeholder collaboration to ensure documentation aligns with global medical device standards (e.g., EU MDR, FDA).
- Authored Comprehensive Regulatory and Clinical Reports Clinical Evaluation Reports (CERs): Including State of the Art (SOTA), safety and performance analysis, and clinical data review.
- Clinical Evaluation Plans (CEPs): Outlining methodologies, objectives, and systematic literature review strategies.
- Post-Market Surveillance (PMS) Reports: Incorporating proactive/reactive data, sales/complaints analysis, and CAPA assessments.
- Usability Reports: Conducting summative evaluations, risk assessments, and validation studies for Class 1 medical devices.
- Used COGNIDOX to create product technical file packages for all class devices.
DHF Remediation Engineer
Cyient Ltd
Hyderabad
01.2022 - 04.2024
- Technical File Audit Checklist and Design History File (DHF) remediation per EU MDR 2017/745 for Medical devices
- Clinical Evaluation Plan and Report (CEP and CER) creation for Medical devices
- Gap Assessment between old and new ASTM, ISO standards
- Post Market Surveillance Plan (PMSP) and Periodic Safety Update Report (PSUR) creation for Medical devices
- Creation of Biological Evaluation Plan (BEP) for Medical devices
- Creation of documents in controlled document database, Windchill, 200+ Documents which includes windchill admin for Change Notice for Memo's and other documents
- Creation of Approval Requests for Test reports and DCTM renumbering in Windchill
- Creation of Test Report Gap Assessment Memo's (Analysis of Test Reports and creation of rationale for missing information, including worst case analysis)
Regulatory Analyst
HCL Technologies Private Ltd
CHENNAI
08.2018 - 10.2020
- Gap assessment and remediation as per EU IVDR 2017/746
- Preparation of Technical file (STED), GSPR, Performance evaluation reports (PER kit) - Performance Evaluation Plan (PEP), Scientific Validity Report (SVR) for various products
- Systematic Literature Review for scientific writing (Ovid, PubMed, Embase)
- Authoring Clinical Performance Reports by literature search
- Peer review of the deliverables
- Product Quality Assurance by final inspection of the deliverables
Junior Biomedical Engineer
Sri Ramachandra University & Hospital
07.2016 - 07.2018
- Worked efficiently with various departments and teams and relayed new development on product line
- Maintenance and troubleshooting of medical equipment like Patient Monitor, Anesthesia Ventilator Etc
- Clinically as well as technically
- Follow up the Preventive Maintenance and Calibration schedule for medical equipment
- Reduced medical equipment downtime through preventive maintenance procedures
- Ensuring compliance to quality standards and maintaining all quality control documents
Education
Bachelor of Engineering - Biomedical Engineering
SSN College of Engineering
Kelambakkam, India 05.2011 - 05.2015
Skills
EU IVDR 2017/746
EU MDR 2017/745
Scientific writing
Systematic Literature Review
Medical Writing
Regulatory affairs
Post-marketing surveillance
Risk management
CAPA management
Clinical development
Clinical writing
Time management
Teamwork
Websites
Personal Information
- Date of Birth: 01/07/91
- Nationality: Indian
Awards
Most Valuable Performer Bronze, Cyient, 01/01/22, 04/30/24, Exhibited great collaboration and technical expertism to enhance the business. Received good feedback on the deliverables and delivered in a short time with quality of time. Received SPOT appreciation for the dedication showed towards the project.
Platforms
- COGNIDOX
- WINDCHILL
- SAP
- BOMcheck
- OVID
- PUBMED
- EMBASE
Timeline
Regulatory Affairs Specialist
Upshot Engineering LLP
09.2024 - Current
DHF Remediation Engineer
Cyient Ltd
01.2022 - 04.2024
Regulatory Analyst
HCL Technologies Private Ltd
08.2018 - 10.2020
Junior Biomedical Engineer
Sri Ramachandra University & Hospital
07.2016 - 07.2018
Bachelor of Engineering - Biomedical Engineering
SSN College of Engineering
05.2011 - 05.2015
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