Regulatory Affairs Associate

3 weeks ago

Sydney, Australia TRESP Recruitment Full time

Contribute to cutting-edge medical device advancements
- Excellent opportunity for career development
- Join a collaborative & innovative team

**The Company**

A worldwide healthcare leader that is on a mission to deliver innovative solutions in various areas in the healthcare space. Since its establishment, the company continued to make its mark in healthcare by expanding its product offering in medical devices.

**The Role**

Based in North Ryde, this is an integral role that will see you supporting the regulatory department to ensure efficient and complaint business processes and environment. You will be contributing to the overall success of the team by performing a variety of administrative tasks to facilitate regulatory activities.

This is a 10 month contract with possibility for extension.

Your key responsibilities will include:

- Prepare documentation needed for regulatory submissions in Australia and New Zealand.
- Determine and document the impact of design/process changes on device approvals.
- Assess the acceptability of documentation for submission to the TGA.
- Draft Australian specific regulatory documentation.
- Review and approve advertising and promotional items to ensure regulatory.

**About You**
- Experience in regulatory affairs is highly desirable.
- Strong attention to detail.
- Excellent verbal and written communication skills.
- Computer literacy skills.
- Strong team spirit.

**What we offer?**
- Competitive Remuneration Package ($40-45/hr + Super)
- Hybrid model - 2 days in office.
- Opportunity for career development.
- Supportive workplace culture.

**0450 688 312**:

- ) _for a confidential discussion.

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