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South San Francisco

    Manager, Medical Device - South San Francisco, United States - Experis

    Experis background
    Scientific
    Description
    Senior Manager, Medical Device Technology, Complaint Handling

    Our client in

    South San Francisco

    is looking for hardworking, motivated talent to join their team.

    Don't wait... apply today

    What's in it for you?

    Pay range $85 - $92/hr/W2
    100 %Onsite, Contract Full-Time Position

    Location:
    South San Francisco, CA

    Job Description


    In this role, you will lead Complaint Investigation process and execution for product design and process related complaints for our Post-Market Medical Device Invitro Diagnostic (IVD) Products within our Design Engineering team.


    Ensure that all applicable Medical Device Regulations for Complaint Handling are incorporated within local SOPs and work instructions and followed.

    Developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines.
    Maintain a compliant process for Complaint Files aligned with 21 CFR Part
    Maintain a complaint process for Post marketing Safety Reporting (PMSR)
    Specialize in leading complex cross-functional investigations teams, signaling/trending within and across complaint data
    Ensure appropriate and timely flow of complaint investigation review and approval
    Lead complaint monitoring and trending activities, such as data analysis, internal/external audits, CAPA related activities, post market surveillance
    Work with software partners to enhance existing complaint handling systems. Participate in software verification and validation when required

    Qualifications-Must-Have

    Bachelor's Degree and 8+ years of experience in complaint handling.


    Experience working with and knowledge of 21 CFR , and 21 CFR Part 803.
    Demonstrated experience with leading teams responsible for post market complaint investigations for medical devices
    Experience in Regulatory Agency/Health Authority interactions
    Experience in working with Combination Products and Medical Devices
    Excellent understanding of local regulations around good manufacturing practices
    Experience in relevant guidelines, operations and/or quality.

    What's in it for you??

    Competitive hourly pay paid weekly
    Medical, Dental, Vision and 401K benefits
    Access to free up-skilling tools and resources


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