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Regulatory Affairs Associate
2 months ago
About Us
Device Technologies Australia Pty Ltd is a leading medical solutions provider dedicated to improving patients' lives through innovative technology and services. With over 30 years of experience, we have established a reputation for quality, dedicated service, and ongoing support.
Our Culture
We foster a culture built on empowering our people to achieve their goals, aligning with wider business objectives. Our focus is on productivity, continuous improvement, career development, and leadership nurturing to create a superior workforce.
The Opportunity
We are seeking a self-motivated Regulatory Affairs Associate to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring a high level of quality, safety, and efficacy is assured throughout the life cycle of medical devices.
Your Key Responsibilities
- Work closely with internal and external stakeholders to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to solve problems related to regulatory affairs in the supply chain.
- Develop and maintain relationships with ANZ regulators, the TGA, and Medsafe to ensure compliance with local requirements.
About You
We are looking for a candidate who is passionate about delivering high-quality healthcare products to Australian and New Zealand patients. You will be a self-motivated problem solver with excellent communication skills and a strong understanding of regulatory requirements.
Requirements
- 3-5 years of experience working with the TGA in medical device regulatory submissions for Class I-IIb.
- Working knowledge of the New Zealand medical device requirements.
- Experience solving regulatory-related problems in the supply chain and working with cross-functional teams.
What We Offer
We offer a dynamic and supportive work environment, opportunities for career growth and development, and a competitive salary package. If you are a motivated and experienced Regulatory Affairs Associate looking for a new challenge, please apply for this exciting opportunity.
