Ramgopal Sivanadham
SPSR Nellore
Summary
As a senior manager in IVD medical device industry, I offer highly credible technical leadership, guiding Regulatory, Quality, and cross-functional teams towards complete regulatory compliance, QMS, Testing, and system development and implementation across global markets. I am experienced in managing diverse teams of developers, analysts, quality and regulatory professionals on complex projects and regulatory readiness. I possess a solid background in IVD regulations, am certified in EU IVDR 2017/746, and am a recognized leader in people management.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior Project Manager
HCL Technologies Pvt Ltd
04.2021 - Current
- Delivery management and Projects management for In vitro diagnostics (IVD) and Medical Devices and Reagents
- Certified EU IVD Medical device regulations (CE Marking and FDA regulations) – Testing and Compliance Documentation
- Global IVD and Medical device regulations – Testing and Compliance Documentation
- Verification and Validation Testing of IVD Medical devices
- IVD Medical device complaints investigation and root cause analysis
- IVD Medical Device Clinical performance testing (Trials) – monitoring, analysis, report preparation, and review
- R&D and Assay development for IVD products
- Design and Development of IVD Medical devices
- Stability testing, Benchmarking, and other sustenance testing IVD medical devices
- Regulatory affairs areas
- EU IVDR 2017/746 – In vitro Diagnostics Regulation – European Union
- US FDA Regulations – 21 CFR – 510(k), PMA, and QSR (21 CFR 820)
- NMPA Regulation – China
- Therapeutic Goods Administration (TGA) Regulations – Australia
- ISO 13485 – Quality Management System and MDSAP (Medical Device Single Audit Program)
- IEC 62304 – Medical Software – Software lifecycle processes
- ISO 14971 – Risk Management System (Risk Plan, Risk Classification of failures, FMEAs, and Risk Management Report)
- Training and Monitoring for Freshers and New hires
- Organizational capabilities documents preparation and sales team support
- Max team size handled: 55
Senior Analyst (IVD Medical Devices)
MakroCare Clinical Research Ltd
10.2019 - 04.2021
- Regulatory expert, EU and FDA, technical documentation for regulatory submissions
- Notified body (BSI and TUV) audits and closing findings for CE marking
- Verification and Validation testing for IVD medical devices
- Gap analysis of IVD medical devices for CE marking under IVDR EU 2017/746
- Performance Evaluation Report (PER) writing and review for IVD medical devices according to Regulation EU 2017/746 (For CE Marking)
- EU Classification for IVD medical devices (Class A, Class B, Class C, and Class D)
- Scientific Validity, Analytical Performance, and Clinical Performance reports preparation and review according to IVDR
- Risk Management System (ISO 14971) reviewing
- Post-Market Surveillance (PMS) report according to ISO/TR 20416
- Benefit-Risk evaluation report, and concluding evaluation
- Literature analysis and summaries writing and review
- Technical Documentation (STED) preparation and compilation according to IVDR
- Review and finalize the responses for the Regulatory Notified Body auditing for CE marking
R&D Scientist – I
PathnSitu Biotechnologies Pvt. Ltd.
Hyderabad
08.2018 - 09.2019
- Verification and Validation of IHC devices and reagents
- Handling real life clinical samples (Tissue, Cell Suspension, Blood, and Urine) and maintain the quality
- Quality review (R&D and Quality control lots) for IVD products (Antibodies, buffers, other reagents)
- Performing Immunohistochemistry (IHC) for the cancer diagnosis purpose
- Developing and validate new protocols for the new IHC markers (R&D level)
- Troubleshooting, Documenting, cGLP, SOPs, and DHFs preparation and maintenance
- Field failure complaints and Field return products investigation
- Field failure and returned product RCA and CAPA validation
- Read IHC and Special stain slides for inhouse QCs and end user complaint QCs
- Involve and manage in the conversion of manual staining process to automation (NPD)
- Developing and validate FISH products, hybridizer, and protocol (R&D level)
Senior Research Associate
Madurai Kamaraj University
Madurai
10.2016 - 07.2018
- Collection and handling clinical samples (Cell Suspension, Blood, and Urine)
- Performing Tissue Cross Matching (Immunocytochemistry) for the Organ transplantation
- 'HLA gene' genotyping by PCR-SSP method
- Testing rejected organs
- Cadaveric organ matching for emergency Organ transplantation
Research Fellow (JRF and SRF)
Madurai Kamaraj University
Madurai
07.2013 - 09.2016
- Collection and handling clinical samples (Cell Suspension, Blood, and Urine)
- Doing research on Immunogenetics of Autoimmune Diseases
- Publishing research findings, Teaching Immunology to M.Sc students
- Performing Immunology laboratory techniques and teaching to M.Sc students
- Basic Research on Immunogenetics
Education
Ph.D. - Immunology
Madurai Kamaraj University
Madurai09-2018
Master of Science - Industrial Microbiology
Sri Venkateswara University
Tirupati07-2011
Bachelor of Science - Microbiology
Sri Venkateswara University
Tirupati07-2009
High School Diploma -
Viswodaya Govt Junior College
Venkatagiri07-2006
High School Diploma -
ZP Boys High School
Chennur07-2004
Skills
- EU IVDR 2017/746
- EU MDR 2017/745
- Quality Management System (QMS) - ISO 13485
- US FDA - Quality System Regulation (QSR)
- Regulatory Technical DOcumentation (STED)
- Design History File (DHF)
- Risk Management (Plan and Report)
- Delivery and Project Management
- International Client Interface
- Verification and Validation testing
- Assay Development
- Lateral Flow and Rapid Testing
- Point of care testing
- Companion diagnostics
- Biostatistics
Languages
Telugu
First Language
English
Proficient (C2)
C2
Hindi
Elementary (A2)
A2
Tamil
Elementary (A2)
A2
Certification
- Project Management Professional (PMP) - Project Management Institute.
- Certified EU IVD Medical Device Regulations (IVDR 2017/746).
- Certified in Immunohistochemistry.
- Certified People Manager.
Accomplishments
- Best Thesis award-2018, School of Biological Sciences, Madurai Kamaraj University.
- DBT-IPLS Scholarship 2013 (Madurai Kamaraj University).
- 1st Rank holder in RESET2013, Microbiology (Sri Venkateswara University).
- GATE-2013, Score 444/1000.
- Project Fellow in Watson Life-sciences (2010-2011).
- 82nd Rank holder in PGSET2009 (Sri Venkateswara University).
Research Publications and Conferences
- Published 14 international research publications
- Attended and Presented in 16 International and National Conferences
Affiliations
- National Service Scheme (NSS)
- Cricket player
- Loves cooking
- Gardening
Timeline
Senior Project Manager
HCL Technologies Pvt Ltd
04.2021 - Current
Senior Analyst (IVD Medical Devices)
MakroCare Clinical Research Ltd
10.2019 - 04.2021
R&D Scientist – I
PathnSitu Biotechnologies Pvt. Ltd.
08.2018 - 09.2019
Senior Research Associate
Madurai Kamaraj University
10.2016 - 07.2018
Research Fellow (JRF and SRF)
Madurai Kamaraj University
07.2013 - 09.2016
Ph.D. - Immunology
Madurai Kamaraj University
Master of Science - Industrial Microbiology
Sri Venkateswara University
Bachelor of Science - Microbiology
Sri Venkateswara University
High School Diploma -
Viswodaya Govt Junior College
High School Diploma -
ZP Boys High School
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