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Naeem Abdul salam

is looking for a new team member.

Angestellt, Regulatory Affairs Specialist, Hcl
Frankfurt am Main, Deutschland

Fähigkeiten und Kenntnisse

Technology
Audit
Compliance
Quality Management
Research and Development
ISO
Risk management
GMP
Lifecycle Management
QMS
CAPA
Technical Documentation
ISO 13485
FDA
ISO 9000
Medical device regulation (MDR)
MatLab
Python

Werdegang

Berufserfahrung von Naeem Abdul salam

  • Bis heute 2 Jahre und 9 Monate, seit Sep. 2022

    Regulatory Affairs Specialist

    Hcl

    Maintaining required documents for medical device safety measures and requirements before entering into the market. Especially for Europe and USA . During my service in HCL TECHNOLOGY I have a deep knowledge medical device regulatory regulations for 78 countries I have prepared summary of technical documention for Baxter and J&J for various products I also have deep knowledge in ISO STANDARD for medical device such as ISO13485,ISO10993,IEC 60601,ISO14971,ISO 15223, adverse event reporting and recall

  • 2 Jahre und 1 Monat, Sep. 2021 - Sep. 2023

    Medical device regulatory affairs

    HCL Technologies Germany

    Maintaining required documents for medical device safety measures and requirements before entering into the market. Especially for Europe and USA . During my service in HCL TECHNOLOGY I have a deep knowledge medical device regulatory regulations for 78 countries I have prepared summary of technical documention for Baxter and J&J for various products I also have deep knowledge in ISO STANDARD for medical device such as ISO13485,ISO10993,IEC 60601,ISO14971,ISO 15223, adverse event reporting and recall

Sprachen

  • Englisch

    Gut

  • Deutsch

    Gut

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