Regulatory Affairs Specialist

Requisition ID 2024-14544
# of Openings
1
Job Location(s)
Eight Mile Plains QL Australia
Education
Bachelor's Degree
Position Type
Full Time
Expiry Date
13-6-2024
Category
Regulatory Affairs

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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