Regulatory Affairs Associate - 12 Month Contract

Benefits

Work in a friendly and supportive environment

A global organisation

Flexible working arrangements

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About the company

A leading medical device company with a global reach.

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About the opportunity

On a 12-month contract you will report to the Regulatory Manager and work with Class I medical devices ensuring that they are regulatory compliant for the Australian and New Zealand markets.

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Duties

• Ensure all products currently marketed in Australia and New Zealand meet regulatory requirements, including assessment of variations to existing products

• Respond to TGA/Medsafe request for information

• Perform labelling reviews to ensure regulatory compliance.

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Skills and Experience

• Tertiary qualification in a relevant science degree

• 1-3 years' experience within the Medical Devices industry in a Regulatory Affairs role

• Knowledge of Australian regulatory requirements and guidelines

• Knowledge of CE Marking, EC Certification, Declaration of Conformity

• Strong relationship and negotiation skills with the TGA and or Medsafe

• Ability to work cross functionally

• Excellent team player, proactive and competent

• Effective verbal and written communication

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Culture

The team is easy going and flexible. They are committed to customers and the community and focused on continuous improvement.

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How to Apply

Click apply or contact Davina Ocansey, Recruitment Consultant on +61 2 8877 8712 for a confidential discussion.

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