Regulatory Affairs Associate

1 week ago

Sydney, Australia Device Technologies Australia Full time

**About us**

**Since 1992, Device Technologies has been dedicated to improving patients’ lives through leading edge technology and services, **supplying hospitals and healthcare professionals with high-calibre medical solutions from around the world. Over 30 years, Device Technologies has developed a reputation for the quality, dedicated service and ongoing support provided by our people. With HQ in Sydney, the company continues to grow, representing over 200 trusted brands, and employing over 1000 highly skilled staff located across Australia, New Zealand and Asia.

Geared towards optimal performance, our culture is built on empowering our people to achieve their goals, aligning with wider business objectives. We focus on productivity, continuous improvement, career development and leadership nurturing to foster a superior workforce.

**The opportunity**

In this role you will be responsible for your specific portfolio of medical device TGA and Medsafe registrations, across all classes, including respective records and registrations in online platforms such as SAP and SharePoint. You will have ownership to optimise your own submission strategies in order to meet business deadlines for launch and work closely with internal business stakeholders and external manufacturing partners. In addition to the TGA and Medsafe, you will work within other regulatory frameworks applicable to our products. You will investigate and solve labelling problems identified in quarantined products. You will contribute directly to the success of the Device Technologies business in providing high quality, innovative products to Australian and New Zealand patients.

**About you...**

At Device Technologies, we succeed through our commitment to four key values:
**Delivering Innovation** - We encourage and reward fresh ideas and are committed to supporting our people to make change.

**Seeking Collaboration** - We support each other in our combined mission to help others achieve their goals.

**Taking Ownership** - We believe in equipping our people to take responsibility and accountability in their roles and trust them to get the job done.

**Practising Good Business** - Our success is built on a mix of intuition and experience and we foster an environment where all voices are heard and nobody is afraid to make mistakes.

**Experience required**:

- **Essential**:

- Experience in the medical device regulatory system in Australia (TGA) or a comparable region for a variety of medical device classifications and/or types of products
- **Desirable**:

- SAP and/or SharePoint use

**Interested?**

At Device Technologies we are motivated by the opportunity our equipment provides to change people’s lives. We have a clear vision to ensure all our people feel valued and respected, can be themselves and can flourish as contributors to the success of our business.

Our promise is all qualified applicants will receive consideration for employment without regard to diversity of race, gender, sexual orientation, religion, ethnicity, disability, age and all the other wonderful characteristics that make us different.
- It is also a mandatory requirement for certain roles within our organisation, where the successful applicant may be required to present certifications and/or vaccinations status as per role requirements. Evidence of certificates or vaccination status will be requested during the interview process by management to qualify fit for role and prior to any offer._

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