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Form of workAbout the job
Opportunity to join a leading innovator in musculoskeletal healthcare, with a comprehensive portfolio of products for trauma devices that help restore mobility, alleviate pain, and improve the quality of life for patients. Our Orthopaedics business is growing due to its market-leading products, focus on patient care and education of the orthopaedic community. We are driven by passionate and highly motivated individuals who create a fast and dynamic work environment.
The Role
An exciting opportunity has arisen for a Regulatory Associate role. You will have demonstrated experience with the regulatory affairs preferably within the medical device sector in the management and preparation of regulatory submissions.
The Responsibilities
- Perform clinical literature reviews of medical devices according to regulatory requirements.
- Liaise with Sales and Marketing personnel to assist with the preparation of product registration applications in foreign markets.
- Assist in the development of Clinical Evaluation Reports for regulatory approval.
- Assist in the preparation of records, reports, and other documents required for compiling medical device technical files.
- Assist in any other matters relating to Regulatory Affairs, Sales and Marketing, including but not limited to product risk assessment, technical file review, and the development of surgical techniques and catalogues as requested by the Sales & Marketing department.
- Perform all activities in accordance with company policies & procedures.
- Assist in change control and internal audit processes.
- Development and assist in creation of QMS documents as required.
Other quality & regulatory related tasks as requested by management.
The Requirements
- Demonstrated experience in regulatory affairs preferably in medical devices
- Demonstrated experience in regulatory submissions
- Driven, outcome focused with excellent communication skills.
- Strong work ethic, energetic & self-motivated.
- Strong written and verbal communication.
- Attention to detail.
How to Apply
If you would like to join a growing organisation in a hands-on team environment this is an excellent opportunity to join our team. Please email: ********@austofix.com.au
