Khawaja Hammad

Regulatory Affairs and Compliance Manager at US Surgitech, Inc
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Contact Information
us****@****om
(386) 825-5501
Location
Sialkot, Punjab, Pakistan, PK

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Credentials

  • ISO 13485 Lead Auditor Medical Devices IRCA certified
    IRCA | International Register of Certificated Auditors
    Mar, 2023
    - Oct, 2024
  • Cleanroom & EO Sterilization Validation
    SGS
  • ISO 13485
    IRCA | International Register of Certificated Auditors
  • ISO 9001 Lead Auditor - Quality Certification
    IRCA | International Register of Certificated Auditors
  • MDR Technical Documentation
    SGS

Experience

  • US Surgitech, Inc
    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs and Compliance Manager
      • Jul 2023 - Present

      Managing CE and FDA compliance for class 1, IIa and IIb (class 2) both active & non-active devices used in Robotic, Laparoscopic and General Surgery procedures. Leading Product Registrations in FDA, EU Competent Authorities, PMDA, ANVISA, MHRA. Managing CE and FDA compliance for class 1, IIa and IIb (class 2) both active & non-active devices used in Robotic, Laparoscopic and General Surgery procedures. Leading Product Registrations in FDA, EU Competent Authorities, PMDA, ANVISA, MHRA.

  • Freelance
    • Egypt
    • Human Resources
    • 1 - 100 Employee
    • RA&QA Medical Devices Consultant
      • Aug 2018 - Jul 2023

      > RA & QA with specialized expertise in EU MDR, MDD & UKCA technical files construction for Surgical & Electrosurgical Industry. Lead Auditor for ISO 13485 & ISO 9001 with 8+ years of experience based in Sialkot. > I have expertise of CE marking of medical devices including Active and Non-active medical devices, UDI, SRN, product registration in EUDAMED & MHRA. > EU NB SGS and MTIC have approved my Technical Files including Sterilization based on ISO 11135. Approved Golden Technical File (No CAR) by SGS Belgium. Show less

  • Tecno Instruments Pvt Ltd
    • Pakistan
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Manager
      • Jun 2014 - Jul 2023

      Electrosurgical Instruments Technical Files preparations on MDR, MDD, UKCA & FDA 510(k). QMS implementation and process validations. Internal Auditing & dealing external & clients audits. Sterilization Validations of 2 in-house EO Plants based on ISO 11135. Electrosurgical Instruments Technical Files preparations on MDR, MDD, UKCA & FDA 510(k). QMS implementation and process validations. Internal Auditing & dealing external & clients audits. Sterilization Validations of 2 in-house EO Plants based on ISO 11135.

  • S.R.R Surgical
    • India
    • Retail
    • QA Manager
      • Aug 2018 - Aug 2019

      > Sterile & Non-sterile Surgical Instruments Technical Documentation, Implementation of QMS System based on ISO 13485, Internal Auditing, handling Notified Bodies audits, CAPA, MR Meetings > Sterile & Non-sterile Surgical Instruments Technical Documentation, Implementation of QMS System based on ISO 13485, Internal Auditing, handling Notified Bodies audits, CAPA, MR Meetings

Education

  • Victoria University
    Bachelor of Engineering - BE, Mechanical Engineering

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