Regulatory Affairs Specialist

Benefits
• Join a global leader in the Healthcare industry.
• Regulatory Affairs role to join a supportive and friendly team.
• Competitive salary package on offer + Bonus

About the Company
Our client is a global leader in healthcare technology, specialising in innovative Healthcare Systems and products. With a strong presence in Australia, they are renowned for their cutting-edge solutions that improve patient care globally.

About the Opportunity
As a Regulatory Affairs Associate, you will manage regulatory activities for our client's Healthcare Systems and Technology business in Australia and New Zealand. Reporting to the Regulatory Affairs Manager, you will play a vital role in ensuring compliance, contributing to the company's success in the market.
This role is a hybrid position so you will have the opportunity to work from home as well as the office.

Duties
• Compile and submit regulatory submissions.
• Manage specific product/project regulatory activities.
• Evaluate technical information and implement strategies.
• Provide regulatory advice and ensure compliance.
• Keep abreast of regulatory changes.

Skills and Experience
• Tertiary qualification in medical science, biotechnology, pharmacy, or related scientific discipline.
• 2-3 years hands-on Regulatory Affairs experience, including filing and managing TGA submissions for medical devices.
• Good knowledge of relevant regulatory guidelines and regulations.
• Experience in preparing and filing TGA submissions for Class III medical devices is highly preferred.
• Ability to identify compliance risks and escalate when necessary.
• Demonstrated ability to exercise independent judgment.
• Strong written and verbal communication skills.

Culture
Join a collaborative, innovative, and supportive team dedicated to making a difference in healthcare.

How to Apply
Contact Gemma Staddon, Specialist Manager, for a confidential discussion at 02 8877 8776 or click "apply" to submit your application.