Karthic Kumar
Senior Regulatory Compliance Analyst | Expertise in Medical Device & Animal Health Regulatory Affairs | Skilled in Regulatory Submissions, QA & Risk Management | Proven Track Record in CE Marking & FDA 510(k) Processes
- Role
- Senior Analyst - Regulatory Compliance Merck Animal Health at HCLTech
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Karthic Kumar
I’m a motivated and results-driven professional specializing in regulatory affairs, compliance, medical writing, and quality assurance. I have strong experience in interpreting and applying complex regulations, preparing clear and precise documentation, and ensuring consistent adherence to quality and compliance standards.
Experience
Senior Analyst - Regulatory Compliance Merck Animal Health
Mar 2023 — Present · Chennai, IN
Identify, interpret, and implement applicable operations as per regulatory requirements for the Manufacturing site.• Work collaboratively with cross-functional teams (Manufacturing & Quality) to ensure compliance is integrated throughout the product lifecycle.• Maintain detailed records and documentation of all compliance activities.
Education
Loyola College
Master of Science (M.Sc.), Biomedical Sciences, General
2007 — 2009
Edayathangudi G.S. Pillai Arts & Science College, Nagapattinam - 611 001
Bachelor's degree, Biotechnology
2004 — 2007
Skills
- Microbial Genetics
- Spunlace Nonwoven
- Statistics
- Nanomaterials
- Medical Textiles
- Image Analysis
- Pcr
- Silk
- Wound Care
- Microbiology
- Immunology
- Pathology
- Tissue Engineering
- Technical Textiles
- Experimental Design
- Nanotechnology
- Cell Culture
- Bioinformatics
- Molecular Biology
- Fluorescence Microscopy
- Electrospinning
- Elisa
- Sds-Page
- Protein Purification
- Scaffold
- Afm
- Imagej
- Stem Cell Research
- Image Processing
- Biomaterials
- Hplc
- Nanofibers
- Western Blotting
- Nanofiber
- Cell Viability Assays
- Scanning Electron Microscopy
- Primary Cell Isolation
- Teaching
- Microscopy
- Recombinant Dna Technology
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