Regulatory Affairs Specialist

3 weeks ago

Eight Mile Plains, Australia Cook Group Full time

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 mínimal 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

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