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    Project Manager - Saint Paul, United States - Intellectt Inc

    Intellectt Inc
    Intellectt Inc Saint Paul, United States

    3 weeks ago

    Intellectt Inc background
    Description

    Role: Project Manager (Medical Device)

    Location: St. Paul, MN or Temecula, CA

    Duration: 12 Months on W2

    Shift Timings: 8 AM to 5 PM

    Skills Looking For:

    Implementation of the Eudamed platform to ensure compliance with EU MDR.

    Coordination with multiple functional groups within the organization.

    Compliance with EU MDR requirements, particularly focusing on UTI and device registration, vigilance, post-market surveillance, and clinical investigations.

    Medical device industry experience is strongly preferred and will be given preference.

    May consider pharma background program manager experience who has handled projects on a large scale but first preference will be med device background.

    Familiarity with IT systems and their integration into the project would be beneficial.

    Experience with EU MDR and IT systems integration is a plus.

    Strong leadership, communication, and organizational skills

    Experience in medical devices and familiarity with EU Medical Devices Regulation (MDR)

    Program management experience, preferably with exposure to regulatory affairs.

    PMP certification is a plus.

    Candidates with a regulatory affairs background and extensive experience in program management are also fine provided they have driven large-scale projects till the end.

    Day-to-day Responsibilities: Coordinate with functional teams to identify compliance requirements; Educate team members on regulatory requirements and drive compliance schedule; Communicate and coordinate with IT professionals for system integration; Monitor and drive closure of activities through implementation.

    Education and Level of Experience:

    Bachelor's degree in a relevant field.

    PMP certification is a plus.

    3 to 6 years of experience in program management in the medical device industry.

    Open to looking at candidates with 10 years of experience if they are fine to work at a given bill rate.

    Top 3 Skills:

    Strong leadership and communication skills.

    Ability to comprehend and translate complex regulatory requirements into actionable plans.

    Exceptional organizational skills and ability to drive deliverables to completion.

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