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Quality Assurance And Regulatory Affairs Incharge

Gokul Kv

Scientific Writing

Kerala, India
2 Years
Joined Apr 2026
Trinox Medcorp Private Limited
0 Consultations

About me

Quality Assurance and Regulatory professional with an M.Sc. in Biochemistry and experience in medical devices like PMMA based Bone cement, Surgical Implants & Surgical disposables. Expertise in ISO 13485, ISO 9001, CAPA, audits, validation, EtO sterilization, and documentation. I can help students with life science subjects, QA/QC concepts, medical device regulations, resume building, and career guidance.

Interests: My research interests focus on medical device quality systems, ISO 13485 compliance, EtO sterilization, validation studies, cleanroom and contamination control, CAPA, risk management, and regulatory documentation. I am also interested in biochemistry, life sciences, and improving quality and safety in healthcare products.

Skills

BioinformaticsScientific writingQuality AssuranceRegulatory AffairsMedical devicesNew product developmentPharmaceuticalsBiomedical

My Services

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