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    Regulatory Affairs Specialist - South Plainfield, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences South Plainfield, United States

    3 weeks ago

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    Description
    Responsibilities:
    • Provides administrative support for regulatory affairs manager
    • Provides RA support for change control projects and sustaining activities
    • Conducts regulatory assessments and determines need for re-registration for proposed device changes, prepares internal documentation for changes not requiring re-registration (FDA, EU, OUS)
    • Supports worldwide product registrations through collaboration with regulatory associates and cross-functional product team
    • Responds to requests for product information by customers or other businesses
    • bility to carry out the above tasks with minimal supervision
    • Experience with disposable medical devices
    • Experience with International registrations and renewal.
    Requirements
    • Minimum Bachelor's degree; strongly preferred in science or engineering
    • Minimum 1-3 years' experience in Regulatory Affairs in the medical device industry
    • Demonstrated customer service, cross-functional collaboration, and teamwork skills
    • Proven ability to manage multiple project deliverables and meet project timelines
    • Effective written and verbal communication skills
    • Scientific and analytical evaluation skills US FDA medical device regulations, standards, and guidance
    • 21 CFR 820 - Quality System Regulation.


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