Medical Device Expert in Risk Management ( m/w/d ).

Job ID: 10862

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Type of employment
Project Consulting
  • Ensure timely completion and quality of the assigned risk management files
  • Lead specific risk management activities within projects, as agreed with project leaders
  • Facilitate development and completion of risk assessments.
  • Ensure compliance with ISO 14971 in all development projects assigned
  • Conduct and provide guidance on the use of risk analysis for Use, Products, Components and Processes
  • Ensure compliance with regulatory and normative guidelines focusing on medical device risk management
  • Guide internal and external functions on creating, reviewing and approving medical device Risk Management Files
  • Work with device development team to incorporate and complete Risk Management during all design phases for new and/or product enhancements
  • Apply FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects
  • Author the documentation in the medical device risk management file
  • Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions
  • The ideal candidate would have experience generating DHF (Design History File) documentation.
    Requirement for the role are:

    • Excellent technical writing skills (e.g., Design Controls)
    • Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
    • Experience in Product Design and Design for Manufacturing
    • Good technical knowledge of primary containers development (e.g. prefilled syringe)
    • Good technical knowledge of autoinjector development
    • Good communication skills
    • General understanding of Human Factors Engineering and Risk management
    • General understanding of clinical trial processes and requirements
    • General understanding of pharmaceutical development