Shahin Fouladvand

Bis 2022, Chief Compliance Officer, Nu-Vision

Surbiton, Vereinigtes Königreich

Fähigkeiten und Kenntnisse

Quality Management
Risk Management
Regulatory Affairs
Total Quality Management (TQM)
Continuous Improvement
ISO 13485
MDD 93/42/EEC
MDR 2017/745
CAPA
NC
Internal Audit
Supplier Audit
Human Tissue
EFQM
Design History File
CE Mark Submission
Field Safety Notice
Product Recall
ISO 14971
ISO 9001
Vigilance Report
Processes
FSCA
Projektmanagement
Management
Consulting
Compliance
Change Management
Technology

Werdegang

Berufserfahrung von Shahin Fouladvand

  • 2 Jahre und 1 Monat, Juni 2021 - Juni 2023

    Global Quality, Regulatory and Risk Management Consultant

    Beckton Dickenson

  • 2 Jahre und 4 Monate, März 2020 - Juni 2022

    Chief Compliance Officer

    Nu-Vision

  • 6 Monate, Jan. 2021 - Juni 2021

    Post Marketing Surveillance Lead

    RDT

  • 1 Jahr und 6 Monate, Sep. 2019 - Feb. 2021

    Regulatory Affairs project Manager

    ConvaTec (Germany) GmbH
  • 1 Jahr und 5 Monate, Sep. 2019 - Jan. 2021

    QA/RA Project Manager

    ConvaTec (Germany) GmbH
  • 2 Jahre und 3 Monate, Juni 2017 - Aug. 2019

    Quality&Risk Consultant

    Maquet Cardiopulmonary GmbH / Getinge Group

  • 1 Jahr und 11 Monate, Juli 2015 - Mai 2017

    QA/RA Manager, International

    Wright Medical (UK) LTD

    Orthopaedics/Biological Medical Device Class I, II a &b and III /Human Tissue. Quality Management, Risk Management, Regulatory Affairs, Lead and implement ISO 13485 and 14971, 93/42/EEC requirement Global Quality System Harmonization team, External Bodies related to Quality and Regulatory affairs, MHRA Review and assessment of EC and FDA, CMDCAS, TGA Technical Documentation and act as Responsible Person “RP”, (DHF) and (DMR)

  • 6 Monate, Jan. 2015 - Juni 2015

    QA/QC Director

    Palanir

    Lead the QA/QC team for all processes (training, document control, audits, NCRs, CAPA, supplier management)

  • 1 Jahr und 5 Monate, Sep. 2013 - Jan. 2015

    Global Risk& Quality Management Consultant (GRQP)

    DePuy Synthes

    ISO 13485, EC93/42/EEC and ISO 14971; DHF, MDR and RMR, Design & Clinical Risk Management, Risk Management Report, and Risk Management Plan; DFMEAs and PFMEAs

Ausbildung von Shahin Fouladvand

  • 2 Jahre und 1 Monat, Sep. 2007 - Sep. 2009

    Risk and Compliance Management

    University of East London

  • 4 Jahre und 7 Monate, Sep. 1994 - März 1999

    Industrial engineering and management

    Islamic Azad University of Tehran-South

Sprachen

  • Englisch

    -

Interessen

Football
Reading
Watch TV

21 Mio. XING Mitglieder, von A bis Z