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Thomas David
Regulatory Engineer
Chennai
Summary
4+ years’ experience in Medical Domain and currently working as Quality and Regulatory Specialist at TCS, Bangalore. Expertise in Regulatory Compliance, UDI, Labelling, Packaging, Usability, Risk Analysis and Clinical Evaluation.
Overview
6
6
years of professional experience
6
6
years of post-secondary education
3
3
Languages
Work History
Regulatory Affairs Associate
Tata Consultancy Services (TCS)
Bangalore
10.2020 - Current
- Gathered, evaluated, organized, managed and collated information in varying formats.
- Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures.
- Consolidated global information relevant to [Product or Service] and monitored global submissions and approvals status.
- Prepared and submitted regulatory file applications and supporting documentation.
- Kept up-to-date with changes in regulatory legislation and guidelines and obtained marketing permissions.
- Led product teams of [Number] for regulatory product compliance on [Product or Service].
- Prioritized project-related tasks to efficiently complete essential tasks.
- Maintained and archived regulatory paperwork.
- Reviewed [Type] data to assess compliance with [Type] regulations.
- Implemented regulatory guidance procedures for [Area of expertise].
Senior Associate
Freyr Global Regulatory Solutions and Services
Hyderabad
04.2020 - Current
- Prepared Gap analysis checklist based on regulations available on the USFDA, Malaysia, Mexico databases.
- Supported client for product registration in respective countries Mexico, Malaysia, US, EU.
- Compiled technical documentations, declaration of conformity, verification reports and non-technical documents.
- Assisting client in preparation in justification reports to sort out queries from notified bodies, regulatory authorities.
- Prepared SOP, templates, WI required for each country specific, product specific to ease project progress.
- Co-ordinating with client and regulatory authorities throughout the product registration to ensure hassle free submission.
- Preparation of search strings for PUBMED, M-strings database, review, screening of explicit articles to show evidences.
- Prepared summarization of articles for providing clinical evidence to demonstrate product performance, clinically safe.
- Expertise on Risk assessment of medical devices in compliance with ISO 14971
- Prepared Scientific Validity reports for demonstrating compliance of the IVD with (EU) 2017/746 by summarising the research and review articles as evidences.
- Worked in compiling 510K submissions packages, Pre-submissions to USDFDA.
- Establishment Registration and Device Listing (DRLM/FURLS)
- Determining and applying for small business models (reduction in 510(k) fee)
- Performing RTA checklist gap correction and informing the client what additional information is required.
Associate
Bull Academy & IT services
Chennai
10.2018 - 01.2020
- Involved in gap assessment and remediation to establish compliance for EU MDR 2017/745 and MDD 93/42/EEC regulations.
- Performed detailed gap analysis on renal disposables, Solutions, Dialysis machines and containers used in Haemodialysis and Peritoneal dialysis therapies with respect to Annexure-I GSPRC of MDR.
- Performing in depth gap analysis on product to identify gaps in bio-compatibility, Packaging, Stability Assessments.
- Performing ISO standards breakdown and checking compliance of product with respect to State of the Art (SotA).
- Creation of Requirement documents, Sub-system requirement documents for the identified gaps with adherence to QMS system, Redlining the Requirement document and responsible for complete ownership of routing the same updated Requirement document into TCU.
- Creation of General Verification reports, Technical Rationale and Memo documents.
- Perform Labelling verification study, Labelling verification protocol and report creation.
- Updating and creation of Design History File (DHF) Index, Summary Technical Documentation (STED) based on Annex II of MDR, GSPR Checklist for regulatory submission with inputs from global regulatory.
- Assigned with responsibilities of Change control Management.
- Identification of relevant impact assessment for a particular product change from regulatory point of view with reference to internal quality documents.
- Co-ordinating with cross tower stakeholders for assessment closure and change plan creation.
- Knowledge of product standards ISO 8637.
- Creation of Post Market Surveillance Plan based on Annex III of MDR.
- Developed Packaging Engineering Report to support shipping and distribution standard (ASTM D4169) without testing.
- Comprehensive knowledge on Product Development Lifecycle Management (PDLM), Risk Management, Biological evaluation (ISO 10993 Series), Packaging of medical devices (ISO 11607 Series), Performance testing shipping containers (ASTM D4169).
- Joint Practice with internal towers and working with Product Design Owners and Subject Matter Experts on gaps and finalizing tasks.
- Collection and handling of complaints from intake to closure.
- Performed complaint assessment, IMDRF coding, reportability evaluation.
- Complaint investigation (NC’s, CAPA, FSCA, Recall) and CAPA effectiveness evaluation.
Production Engineer
Drill Jig Bushing Company (Madras) PVT.LTD, Chennai
chennai
07.2017 - 09.2018
- Decreased in-house production issues by establishing and coordinating sub-contracting and outsourcing requirements and processes.
- Created engineering documentation for manufacturing processes, equipment specifications and change notices.
- Performed root cause analysis and implemented corrective actions.
- Investigated and proposed corrective actions for quality issues.
- Cost estimating and studying the feasibility for the new enquires from the customer.
- Complete drafting of customer drawing in-order to frame and stabilize processes and operation layouts for new/existing products by means of conducting trials
- Preparation of Control plan, FMEA, PPAP, ECN, ECR and Stage drawing for machining operations, preparation of Process/Product Change Report (PPCR), Change Management records, G8D report, Why Why Analysis, Cause and Effect Analysis.
- Developed standard operating procedures & work instructions for machining processes
- Ensuring all the activities are carried out on time as per the PDCA cycle
Education
Bachelor of Science - Mechanical Engineering
St. Peter’s College of Engineering And Technology
Chennai 06.2013 - 05.2017
Higher Secondary Matriculation Board -
St. Ann’s Matriculation Higher Secondary School.
Chennai 04.2012 - 05.2013
SSLC Matriculation Board -
St. Marian’s Matriculation Higher Secondary School
Chennai 05.2010 - 05.2011
Skills
DHF remediation
ISO 13485 procedures and records
USFDA, Malaysia, Mexico regulatory activities
Biocompatability assessment-ISO 10993
EU MDR & MDD (Regulatory Gap Assessment)
MD-Labelling-21 CFR 801/ISO 15223/EN 1041
ISO 14971-Risk Assessment
Software
Agile
Siemens Teamcenter (TCU)
Trackwise 8
Playing Guitar
Enjoy playing rock music
Timeline
Regulatory Affairs Associate
Tata Consultancy Services (TCS)
10.2020 - Current
Senior Associate
Freyr Global Regulatory Solutions and Services
04.2020 - Current
Associate
Bull Academy & IT services
10.2018 - 01.2020
Production Engineer
Drill Jig Bushing Company (Madras) PVT.LTD, Chennai
07.2017 - 09.2018
Bachelor of Science - Mechanical Engineering
St. Peter’s College of Engineering And Technology
06.2013 - 05.2017
Higher Secondary Matriculation Board -
St. Ann’s Matriculation Higher Secondary School.
04.2012 - 05.2013
SSLC Matriculation Board -
St. Marian’s Matriculation Higher Secondary School
05.2010 - 05.2011