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Medical Device Regulatory Specialist
2 months ago
About Device Technologies Australia Pty Ltd...
We are dedicated to delivering high-quality medical solutions to healthcare professionals across Australia, New Zealand, and Asia.
Our mission is to empower our people to achieve their goals, aligning with wider business objectives, focusing on productivity, continuous improvement, career development, and leadership nurturing.
The role...
As a Medical Device Regulatory Specialist, you will be responsible for ensuring a high level of quality, safety, and efficacy in the life cycle of medical devices. You will work closely with internal and external stakeholders to demonstrate compliance of new products with local requirements.
Key responsibilities include:
- Working with cross-functional teams to solve problems related to regulatory affairs in the supply chain
- Utilizing exceptional relationship skills with ANZ regulators, the TGA, and Medsafe to ensure compliance
About you...
We are seeking a self-motivated problem solver who can make valuable connections in all aspects of the business to understand customer and regulator needs. You will be a team player who takes pride in exceeding targets while being passionate about delivering high-quality healthcare products.
Requirements:
- 3-5 years Australian 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
At Device Technologies Australia Pty Ltd, we value diversity and inclusion. We are committed to providing a work environment that is free from discrimination, harassment, and bullying.
