Madhu R
Regulatory Affairs Associate (Medical Device) @ Vphore Labs Pvt Ltd (Infraeyes) | EU MDR 2017/745 | EN ISO 13485:2016 QMS | EN ISO 14971:2019 Risk Management| EUDAMED | CDSCO | UDI ID | IS 23485 : 2019 | SOPs | PRRC
- Role
- Rdcm Data & Conformance Manager (Associate) at Pfizer
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Madhu R
A certified Medical device Regulatory Affairs Professional and a Registered Pharmacist graduated as Master in Pharmaceutical quality assurance graduate (20••••21). Currently working as \"Medical Device Regulatory Affairs Associate\"@\"Vphore Labs Pvt. Ltd (Infraeyes)\". Involved in following responsibilities like: Authoring high-quality dossier documents preparation for Medical equipment\'s like device master file, site master file, SOP\'s of various equipment\'s used in the manufacturing process, customer feedback analysis, ISO 13485: 2016 i.e, Quality Management System for medical device, EN ISO14971: 2019 i.e, application of Risk Management to Medical Device, SOP: Standard Operating Procedure, ISO: International Organization for Standardization, EU MDR, UDI ID, and EUDAMED.
Experience
Rdcm Data & Conformance Manager (Associate)
Dec 2024 — Present · IN
Education
The National College Basavanagudi Bengaluru
Pre-University, PCMB
Clini Launch Research Institute
ADVANCED DIPLOMA IN CLINICAL RESEARCH AND ALLIED FIELDS, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
New St Florence High School
High School, KSEEB
JSS Academy of Higher Education & Research
Master's degree, Pharmaceutical Quality Assurance
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
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