Regulatory Affairs Associate/Specialist (BBBH36258) Macquarie Park, Sydney, Australia

About the company

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

 

 

 

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.

 

 

 

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.

 

 

 

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

 

 

 

Culture

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

 

 

 

How to Apply

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

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