Regulatory Affairs Associate/Specialist

About the company

An established and highly reputable global medical device company with a range of low to high-risk products.

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About the opportunity

This is a 6-week contract role to cover a paternity leave. You will support the team with ongoing regulatory activities across all portfolios including marketing material reviews.

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Duties

• Assist RA team with planning of product registration activities to ensure regulatory compliance and approval for market access.

• Review and approval of marketing material

• Prepare documents in electronic files for regulatory submission dossiers.

• Maintain technical files for approved products.

• Assist the RA team in developing solutions to problems and present to internal and external stakeholders.

• Liaise with TGA and Medsafe as required.

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Skills and Experience

• Bachelors' degree in relative field - science or engineering

• Minimum of 2 years' regulatory affairs experience within medical device industry

• Solid understanding of TGA and MTAA regulations for medical devices: Class I, II, III

• Must be familiar with current Therapeutic Goods Advertising Code and experience with marketing material review.

• Ability to work independently with limited supervision.

• Proven project management experience

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Culture

A supportive and friendly working environment where people are passionate about their roles and the impact of their products on the patient.

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How to Apply

Click apply or contact Joanna Murphy, Senior Recruitment Consultant on +61 2 8877 8718 for a confidential discussion.

( SK927795A )

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