Er. Chiranjeevi N

Regulatory Affairs and Quality Professional (Contract), Siemens Healthineers, Bengaluru.

DECEMBER'2022 - SEPTEMBER'2024 (21 Months, and 2 days)

Payroll Organization: GSR Business Services, Bengaluru.

Performed duties as a Regulatory Affairs Specialist and Quality Assurance Engineer at Siemens Healthineers, Bengaluru executing responsibilities on-site at client premises. 

• In accordance with EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices Regulation (IVDR) and harmonized standards, generated pre-submission technical documentation for Class A, B, C, and D In Vitro devices, encompassing:

  1. • 1. Product Technical File

       2. Declaration of Conformity (DoC)

       3. Summary of Safety and Performance Report(SSP)

       4. General Safety and Performance Report (GSPR)

       5. Common Specification (CS) checklist

       6. Intended Purpose (IP) assessment 

       7. Product Classification worksheet 

• Achieved successful regulatory approval from the European Union for a total of five Class B, C, and D devices.

• Directed the core team in preparation of pre-submission technical documents for a Software as Medical Device (SaMD) product - PRISCA system, for regulatory submission.

• Authored product approval applications, including documents such as TD Version, Annex A, Product List and Application (PLA - QA & TD), Significant Change Notification (SCN), tailored for Class C and D In Vitro Devices, adhering to TÜV Rheinland template.

• Acted as Single Point of Contact (SPoC) for Notified Body’s (NB) Surveillance Audits, addressing inquiries from NB and liaising with various departments including R&D, labelling, and marketing teams, while also overseeing the preparation and updating of Regulatory Affairs (RA) specific documents.

• Conducted Intended Purpose (IP) assessment, reviewed and approved performance documents such as Performance Evaluation Report (PER), Analytical Performance Report (APR), and Clinical Performance Report (CPR).

• Facilitated EU IVDR training sessions as training coordinator for the entire Siemens Regulatory Affairs (RA) team.

• Provided direction to the EU Authorized Representative (AR) in addressing various queries related to product technical documents for registration with Ireland's Health Products Regulatory Authority (HPRA). 

• Offered assistance for product registration in international markets.

• Collaborated with Core Regulatory Affairs (RA) and Research & Development (R&D) team members to support in Device Classification, NBOG (regulatory) codes identification, product submission, and review of technical documentations.

• Produced Post Market Surveillance (PMS) documents such as US FDA’s regulatory reports (FDA 3500A) for In Vitro Diagnostic (IVD) instruments, and consumables. 

Tools Experienced: RIMSYS, SmartSolve, DocLib, Documentum, D2, SAP P41, Azure DevOps, NORIS, Compass Premium Portal (CPP -TUV’s Product Submission Tool), Adobe Sign, MS SharePoint, MS Lists, MS Tasks and other MS Office 360 and Adobe applications.

Lead Engineer, HCL Technologies, Madurai.

JANUARY 2020 – DECEMBER 2022 (35 Months)

Served roles like Clinical Writer for Abbott Laboratories, and Project Lead, Jr. and Sr. - Data Analyst, DHF Remediation Specialist, Configuration Controller (CC), Process Quality Analyst (PQA) and Quality Assurance Specialist for Johnson & Johnson's subsidies Ethicon, Visioncare, Biosense Webster, Depuy Synthes by operating from HCL Technologies - Offshore Development Center (ODC).

• Lead a team at maximum of 12 members.

• Conducted medical device product data gap analysis, updates, remediation, maintenance, and directed license updates & renewals within the Medical Device Regulatory Information Management System (MD RIMS) Database.

• Provided technical assistance in addressing comments from EU Notified Bodies Audits.

• Conducted literature surveys, screenings, and authored Scientific Validation Reports (SVRs) and Clinical Performance Reports (CPRs) for technical files of In Vitro Diagnostic Medical Devices (IVD).

• Acted as a Subject Matter Expert (SME) for 26 US FDA Medical Regulatory Databases.

• Conducted Gap Assessments for ISO, IEC, ANSI/AMMI, and ASTM standards.

• Performed Risk Management activities like providing solution for device complaints using different types of FMEAs.

• Implemented Risk Management activities including solutions for device complaints utilizing various types of Failure Mode and Effects Analyses (FMEAs).

• Obtained Test License MD13 for 3 In Vitro Devices from CDSCO.

• Developed two automation tools as part of a lean six-sigma project, resulting in reduced effort, time, and costs, mutually benefiting both the project and the client.

• Participated in Quality Process Compliance Audits as a Configuration Controller.

• Conducted Technical Work Product Audits for the Medical Device Labelling project in accordance with ISO 15223-1 & ISO 20417.

• Implemented Corrective and Preventive Actions (CAPA) to address quality issues. 

Rewards & Achievements:

• Published a whitepaper In Vitro Diagnostics Medical Device Classification in Major Countries and Risk Comparison.

• Received Process Championship Award twice.

• Maintained 93% project compliance towards organization’s medical device quality policy (ISO 13485).

• Authored Global Regulatory Affairs Database for Medical and In Vitro Diagnostic Devices regulations.

• Developed Automation Tool using MS Excel Macros and reduced cost to the project and time to the client. 

Tools Experienced: Agile PLM, Adaptive, Windchill, Epicentre, Thunderbird, Common Document Repository (CDR), OVID, PubMed, PMSmart, Professional Association Bodies, Google Scholar, and MS Office 360 applications.

Quality Biomedical Engineer, Trimed Solutions India Private Limited, Hyderabad.

December 2018 – DECEMBER 2019 (12 Months)

Served roles like Bio-Medical Trainee, Jr. Bio-Medical Engineer and Calibration Engineer.

• Played a pivotal role in obtaining NABL Accreditation for a medical device performance testing laboratory.

• Performed Electrical Safety Testing, Performance Testing, Calibration, and Preventive Maintenance for medical device based on ISO/IEC 17025:2017, IEC 60601/62353 & NABL 126 standards at International Standardized Hospitals.

• Conducted Electrical Safety Testing, Performance Testing, Calibration, and Preventive Maintenance for medical devices in compliance with ISO/IEC 17025:2017, IEC 60601/62353, and NABL 126 standards at internationally standardized hospitals.

• Troubleshoot healthcare equipment according to Manufacturer’s Procedures.

• Developed Calibration templates and Standard Operating Procedures (SOPs) for Biomedical and Laboratory Equipment, adhering to NABL and International Standards, incorporating Uncertainty Calculations.

• Created Quality Assurance Report templates for Radiological Equipment in alignment with AERB Standards.

• Certified as a device performance tester for medical devices utilizing various test equipment including: 

  1. • 1. Rigel Unisim Lite Patient Simulator. 

       2. Fluke PS320 Fetal Simulator 

       3. Rigel 288+ Electrical Safety Analyzer. 

       4. Rigel Uni Pulse Defibrillator Analyzer. 

       5. Rigel Multi Flow Infusion/Syringe Pump Analyzer. 

       6. Rigel Uni Therm Electro Surgical Analyzer. 

       7. TSI USA Certifier FA Plus Gas Flow Analyzer. 

Executive Post Graduation Diploma – Quality Assurance and Quality Control (with Medical Device as Major), Institute of Good Manufacturing Practices India, New Delhi.

OCTOBER 2022 – AUGUST 2023

CGPA: 7.92/10.

Bachelor of Engineering – Medical Electronics, Sengunthar College of Engineering, Tiruchengode.

JULY 2015 – APRIL 2019

CGPA: 7.25/10, First Class. 

Journals Published: Advanced Control System for Syringe and Infusion Pump Using IoT.

Achievement:

• National Level Competition Smart India Hackathon’s 2017 & 18 Grand Finalist.

• Received Best Executive Member of the year-2019 and Best Outgoing Student Award and Certificate.

• Received VIT Kalvi Ko. G.Vishvanathan Chancellor Medal.