Naeem Abdul salam

is looking for a new team member.

Bis 2023, Regulatory Affairs Specialist, Hcl
Frankfurt am Main, Germany

Skills

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
Signal Processing
Bci

Timeline

Professional experience for Naeem Abdul salam

  • 1 year and 1 month, Sep 2022 - Sep 2023

    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 years and 1 month, 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

Languages

  • German

    B1-B2 (Good)

  • English

    C1 (Fluent)

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