Faizan Shaikh
Regulatory Professional at Vector Biotek Pvt.Ltd (Beacon Group)
- Role
- Regulatory Professional at Vector Biotek Private Limited
- Location
- Navsari, GJ, IN
- LinkedIn followers
- 500 followers
About Faizan Shaikh
To leverage my extensive pharmaceuticals and Regulatory Affairs background, I am…
Experience
Regulatory Professional
Jun 2024 — Present · Navsari, IN
Maintain and update technical documentation for Class A, B, and C IVD products, including Hematology, Biochemistry Reagents, Rapid Kits, and Analyzers, ensuring compliance with MDR 2017, WHO regulations, and CE marking requirements. Prepare and manage regulatory submissions for CE marking and product registrations while ensuring compliance with global standards. Oversee QMS documentation and compliance with ISO 13485, ISO 9001 and WHO GMP, including internal audits, change control, deviations, and nonconformities. Ensure regulatory compliance of product labeling, product inserts, and artworks while maintaining post-marketing surveillance reports. Assist in responding to regulatory authority queries and external audits, supporting regulatory team leaders with dossier preparation, technical files, and design dossiers. Prepare SOPs and stay updated with the regulatory landscape in the USA, Europe, and India ensuring alignment with evolving guidelines and industry best practices.
Education
Uka Tarsadia University
B.Pharm
2017 — 2021
Gujarat Technological University (GTU)
M.Pharm
2022 — 2024
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