Regulatory Affairs Associate - Medical Devices

Benefits

Wide range of medical devices with all Class of devices.

Be part of a large team who are supportive and collaborative.

Continuous improvement is a focus: investment in your training and development.

About the company

An established, Australian medical device company who supply a wide range of medical equipment and medical consumables across Australia and New Zealand.

About the opportunity

The RA Associate will be responsible for ensuring all new and existing products within their portfolio are registered and compliant with TGA regulations. Your role sits within the Premarket team and will be supported by a large RAQA team. You will liaise with cross functional teams, contract manufacturers, and regulatory bodies such as the TGA and Medsafe.

Duties

• Manage a specific product portfolio and ensure regulatory compliance of product range.
• Prepare and lodge regulatory applications and liaise directly with TGA and Medsafe.
• Maintain regulatory technical files, databases, spreadsheets, and internal registers.
• Liaise with local and overseas suppliers and manufacturers to obtain necessary information and documentation.
• Ensure accuracy and currency of data held relative to product range.
• Develop and maintain strong working relationships with regulatory bodies.

Skills and Experience

• Minimum 2 years of Regulatory Affairs experience working with Medical Devices in Australia
• Degree qualified, ideally in science or engineering
• Previous experience working with TGA and/or Medsafe guidelines.
• Experience with conformity assessments would be advantageous, but not mandatory.
• Must be a natural problem solver and analytical thinker.
• A proactive, team player who also enjoys working autonomously.
• Clear and effective communication will be crucial to your success.

Culture

We look for people who excel in fast-paced environments, who are passionate about their work, and who are collaborative and supportive team players.

How to Apply

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

( SK927795A )