About the company
An established medical equipment supplier to the medical and allied health sector in Australia. A broad product range and a global reach.
About the opportunity
This is a newly created position to provide support to the Regulatory Affairs Manager across the full regulatory function. The portfolio includes Class I, IIa, IIb, III medical devices. For an experienced Regulatory Affairs Specialist this will be a Part-Time position 0.6 FTE.
- Manage dossier compilation for regulatory submission to the TGA/Medsafe and other associated bodies including AICIS
- Maintain regulatory compliance of all products and ensure records are up to date
- Provide guidance on regulatory strategy for new and approved products
- Liaise with business partners and cross functional teams to provide support and guidance on regulatory requirements
- Review and approve advertising and promotional materials ensuring compliance with advertising Codes.
- Evaluate proposed product, labelling and manufacturing changes for regulatory filing solutions.
- Maintain and build strong working relationships with relevant regulatory bodies, business partners, and cross-functional teams
Skills and Experience
- 5+ years' experience for Regulatory Affairs Specialist: Part-Time position
- Tertiary qualifiaction in relevant scientific discipline
- Demonstrated success in analysis and interpretation of regulatory documentation and technical writing
- Knowledge of TGA and Medsafe requirements for Medical Devices
- Experience with management, compilation, submission, and maintenance or regulatory filings
- Excellent communication and negotiation skills
A small company with a strong team spirit. Supportive and collaborative working environment and patient focused.
How to Apply
Click apply or contact Joanna Murphy, Specialist Manager - Regulatory Affairs & Quality Assurance on +61 2 8877 8718 for a confidential discussion.
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