Shashank Pandey

is working from home. 🏡

Angestellt, Regulatory Affairs Specialist, Tata Elxsi

Badlapur, Indien

Über mich

Astute Biomedical professional with 5 Years of experience in client facing Regulatory Affairs and V&V project for medical devices. Continuous learning and utilizing it to improve work environment.

Fähigkeiten und Kenntnisse

EU MDR
ISO 13485
ISO 14971
Microsoft Office
Corporate Communication Management
ISO
Material of Concern

Werdegang

Berufserfahrung von Shashank Pandey

  • Bis heute 7 Jahre und 7 Monate, seit Nov. 2016

    Regulatory Affairs Specialist

    Tata Elxsi

    Onsite project coordinator at client location for project execution Proficiency in EU MDR 2017/745 and ISO 14971 Overview knowledge of ISO 13485, ISO 10993-1 EU MDR gap analysis and remediation activities Create and conduct inhouse training session for EU MDR 2017/745. Project management activities - supporting in creation of project proposal documentation, task & time estimation, creation of best practices documents and guidance documents Process improvement strategy and planning QA Audit Support

Ausbildung von Shashank Pandey

  • 2 Jahre und 11 Monate, Aug. 2013 - Juni 2016

    Biomedical engineering

    University of Mumbai

21 Mio. XING Mitglieder, von A bis Z