SATHISH KUMAR THIRUNAVUKARASU SUBRAMANIAN
QARA Specialist
Philadelphia,PA
Summary
With over [X] years of experience in quality assurance (QA) and regulatory affairs (RA) within the medical devices manufacturing and service sectors, I am a highly skilled and experienced professional. Throughout my career, I have consistently demonstrated the ability to effectively manage and deliver multiple projects while ensuring compliance with industry standards and regulatory requirements.
Overview
2026
2026
years of professional experience
1
1
Language
Work History
Project Manager - Regulatory Affairs
TATA ELXSI
6 2021 - Current
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
- Followed all company policies and procedures to deliver quality work.
- Developed strong client relationships through consistent communication and attentive service.
Technical Lead - Regulatory Affairs
HCL Technologies
08.2019 - 06.2021
- Led a cross-functional team for gap assessment activities for the SuReFInD medical device, ensuring compliance with 510(k), AMDD, and NMPA regulations.
- Coordinated project timelines, resources, and deliverables to meet regulatory and quality standards.
- Conducted comprehensive gap analysis for medical devices, verifying compliance with 510(k), AMDD, and NMPA requirements.
- Implemented gap remediation strategies to address identified compliance issues.
- Performed device usability testing in accordance with EN ISO 62366 standards.
- Conducted safety and durability studies, including durability of markings assessment as per EN ISO 61010-1 and IEC 60601-1 standards.
- Ensured electromagnetic compatibility (EMC) compliance as per EN ISO 61326-2 standards.
- Conducted gap analysis for labelling, operating manuals, instructions for use, and package inserts in compliance with ISO 1041 and EN ISO 15223-1 standards.
- Developed and reviewed regulatory documentation to support product approvals and maintain compliance.
- Utilized RFID technology to enhance the precision of cancer excision during pneumonectomy operations.
- Managed the integration of a microscopic IC tag and its detection via a surgical antenna to assist surgeons in determining the extent of resection.
Senior Executive - QC/QA/RA
Oyster Medisafe Pvt. Ltd.
03.2016 - 07.2019
- Streamlined operations for increased efficiency by identifying bottlenecks in sales processes and implementing targeted solutions.
- Streamlined operations to maximize business efficiency and profits.
- Enhanced customer satisfaction ratings through implementation of targeted programs aimed at addressing specific areas of concern identified via research and surveys.
- Strengthened stakeholder relationships with regular communication, resulting in improved alignment on strategic initiatives.
Supervisor - Production
BBRAUN Medical (I) Pvt. Ltd.
01.2014 - 02.2016
- Oversaw daily operations of the department, ensuring smooth workflow and timely completion of tasks.
- Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows.
- Handled customer complaints, resolved issues, and adjusted policies to meet changing needs.
- Monitored workflow to improve employee time management and increase productivity.
Medical Coder
Dell International Pvt. Ltd.
06.2013 - 12.2013
- Increased coding accuracy by diligently reviewing medical documentation and applying appropriate codes.
- Maintained a high level of productivity while consistently meeting deadlines for claim submissions.
- Reviewed, analyzed, and managed coding of diagnostic and treatment procedures contained in outpatient medical records.
- Reviewed outpatient records and interpreted documentation to identify diagnoses and procedures.
Chemist QA & QC
BBRAUN Medical (I) Pvt. Ltd.
01.2010 - 05.2013
- Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
- Enhanced product quality by developing and optimizing chemical processes and procedures.
- Coordinated and performed analytical tests to comply with established standards and specifications.
- Maintained organized, safe and efficient laboratory environment to minimize accidents and prevent cross contamination.
Chemist QA & QC
Apex Laboratories Pvt. Ltd.
03.2009 - 12.2009
- Coordinated and performed analytical tests to comply with established standards and specifications.
- Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
- Enhanced product quality by developing and optimizing chemical processes and procedures.
- Maintained organized, safe and efficient laboratory environment to minimize accidents and prevent cross contamination.
- Modified and adapted standard methods and procedures to solve analytical problems.
Chemist - Production
Appasamy Ocular Devices Pvt. Ltd.
11.2007 - 11.2008
- Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
- Enhanced product quality by developing and optimizing chemical processes and procedures.
- Coordinated and performed analytical tests to comply with established standards and specifications.
- Maintained organized, safe and efficient laboratory environment to minimize accidents and prevent cross contamination.
Marketing Executive
CIPLA - Respiratory division
08.2007 - 10.2007
- Planned and executed events and marketing programs to increase qualified leads.
- Collaborated closely with sales teams to ensure alignment between promotional activities and revenue goals.
- Analyzed market trends to identify new opportunities for growth, driving the expansion into untapped markets.
- Developed and implemented targeted digital strategy to improve business performance.
Education
Bachelor in Pharmacy - Pharmacy
Dr M.G.R University (Adhiparasakthi College of Pharmacy)
India 01.2003 - 2007.01
Skills
Project Management
Medical Devices
Process Validation
Complain Management
Documentation
Change Control Management
IPQA / QA
Vendor Evaluation
Standards / Guidelines
SAP
Risk Management System
Training and Mentoring
Quality Assurance / Quality Control
Data Analysis
Quality Management System
External and Internal Audits
Project Management
Auditsfaced
- CE Audit - TUV SUD (Notified Body)
- CE Audit - DNV Norway (Notified Body)
- ISO 13485:2016 - DNV (Notified Body)
Internationalexposure
- Japan, 02/17/19, 02/25/19, FAT of new cannula making machine
- Vietnam, 06/10/18, 06/23/18, Sterilization Machine Validation
- Malaysia, 01/22/17, 01/29/17, Syringe new mold qualification
Training
23rd National conference - Indian Pharmacy Graduates Association, Chennai
Disclaimer
I hereby declare that the information and facts stated above are true and complete to the best of my knowledge and belief.
Timeline
Technical Lead - Regulatory Affairs
HCL Technologies
08.2019 - 06.2021
Senior Executive - QC/QA/RA
Oyster Medisafe Pvt. Ltd.
03.2016 - 07.2019
Supervisor - Production
BBRAUN Medical (I) Pvt. Ltd.
01.2014 - 02.2016
Medical Coder
Dell International Pvt. Ltd.
06.2013 - 12.2013
Chemist QA & QC
BBRAUN Medical (I) Pvt. Ltd.
01.2010 - 05.2013
Chemist QA & QC
Apex Laboratories Pvt. Ltd.
03.2009 - 12.2009
Chemist - Production
Appasamy Ocular Devices Pvt. Ltd.
11.2007 - 11.2008
Marketing Executive
CIPLA - Respiratory division
08.2007 - 10.2007
Bachelor in Pharmacy - Pharmacy
Dr M.G.R University (Adhiparasakthi College of Pharmacy)
01.2003 - 2007.01
Project Manager - Regulatory Affairs
TATA ELXSI
6 2021 - Current
Similar Profiles
Anand R LAnand R L
Product Manager at Tata Elxsi LimitedProduct Manager at Tata Elxsi Limited
Gnanadeep ManduvaGnanadeep Manduva
AI Intern at TATA ELXSI LimitedAI Intern at TATA ELXSI Limited
SMRITHI CNSMRITHI CN
Specialist Software Engineer at TATA ELXSISpecialist Software Engineer at TATA ELXSI