Sachin Nandedkar
Pharmaceuticals and Medical Devices Professional
- Role
- Sr Clinical Evaluations Medical Writer at 美敦力
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Sachin Nandedkar
A post-graduate in Pharmacy with a specialization in Clinical Research having 13+ years of experience in Pharmaco-Device Vigilance, Medical Writing for Devices, and Regulatory Affairs. Currently pursuing PGEMP/EMBA from SPJIMR, Mumbai.
Experience
Sr Clinical Evaluations Medical Writer
May 2025 — Present · Hyderabad, IN
Independently creates and maintains CEP, CER, PMCF Plan & Report, and SSCP for medical devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745, MDCG guidance documents and applicable Medtronic procedures and templates.Review/approve other documentation for device development-Reviews IFUs, Risk Management files and other cross-functional documents to ensure alignment of risk information.
Education
Jawaharlal Nehru Technological University
Bachelor of Pharmacy - BPharm
2005 — 2009
Birla Institute of Technology, Mesra
Master of Pharmacy
2009 — 2011
SPJIMR SP Jain Institute of Management & Research
PGEMP/Executive MBA
2023 — 2025
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