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Eight Mile Plains

    Regulatory Affairs Specialist - Eight Mile Plains, Australia - Cook Medical

    Cook Medical
    Cook Medical Eight Mile Plains, Australia

    2 weeks ago

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    Full time
    Description

    Overview

    Fulltime - 12 Months Fixed Term Contract

    Location: Brisbane, Eight Mile Plains

    Hyrbid - work from home 1-3 days a week

    Fantastic opportunity to contribute your skills and experience to this 12-month fixed term specialist role.

    The Opportunity:

    We have an excellent opportunity for a regulatory professional to join our Regulatory Affairs team on a 12-month contract. We are looking for a hard-working, reliable and motivated individual to join a dynamic team where you can establish positive working relationships with your immediate peers and the wider company.

    Responsibilities

    Key Responsibilities include but are not limited to:

  • Perform all tasks in accordance with the Quality Management System to a competent standard.
  • Maintain design dossiers, technical files and other regulatory documents
  • Maintain regulatory affairs project databases and systems which contain regulatory approval information
  • Provide regulatory support on projects, as required
  • Liaise with relevant departments at Cook Australia and at other Cook sites, as necessary, to understand and collate information required for regulatory submissions
  • Prepare device submissions for global markets for products manufactured in Australia
  • Obtain export certificates and legalised documents for submissions
  • Review global marketing materials for compliance to relevant advertising guidelines
  • Participate in internal quality audits
  • Maintain our culture, values and commitment to Ethics and Compliance by recognizing, demonstrating, and enforcing appropriate and compliant behavior

    • Qualifications

    We are seeking people who align with our company values and have a passion for providing quality solutions to our patients. To be successful in this role, you will be able to demonstrate the following skills and experience:

  • Tertiary qualification in either science, engineering, pharmacy or microbiology highly desirable
  • Experience in either quality assurance or regulatory affairs within a highly regulated industry highly desirable
  • Experience preparing regulatory submissions desirable
  • Demonstrated ability to meet deadlines, balancing multiple priorities, and ensuring quality standards
  • Analytical approach to problem solving with innovative thinking and ability to work in collaborative and independent work situations and environments with minimal supervision
  • Highly organised with a focus on attention to detail
  • Approach daily tasks with flexibility, initiative and enthusiasm
  • Effective interpersonal skills including listening, verbal and written communication skills
  • Ability to work effectively in a team environment

    • Please note only applicants that have full working rights within Australia are eligible to apply. Please apply with your CV and a cover letter outlining how you meet the requirements of the role. Shortlisting may commence immediately after advertisement posted.

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