Regulatory Associate

2 weeks ago

Bowen Hills, Australia EBOS Group Full time

**Business**:LifeHealthcare- **Location**:Bowen Hills, QLD, AU, 4006- **Employment Type**:Maximum Term Part Time- Regulatory Associate-
- Be part of something bigger, improving lives across Australia, New Zealand, SE Asia and Hong Kong.-
- At EBOS MedTech, we’re here to improve lives by delivering life-changing solutions for patients that drive positive outcomes in their lives.-
- With a team of over 1,500 people operating in nine countries, we create opportunities to make a real difference for patients, healthcare professionals, and the people who make it all possible: our employees.-
- The EBOS MedTech portfolio of companies includes:- LifeHealthcare - medical device distribution in Australia and New Zealand
- Australian Biotechnologies - allograft manufacturing
- Cryomed Aesthetics - aesthetic technologies across ANZ
- Transmedic - medical device distribution across SE Asia and Hong Kong- We're driven by a passion for improving health and a shared commitment to making a positive impact.- This part-time 8-month contract role presents a fantastic opportunity to be part of a high-performing team managing documentation, data integrity, and manufacturer communication across a portfolio of global manufacturers to ensure the Sponsor meets all its obligations. If you have a high attention to detail and have experience in medical device regulatory or compliance administration then then this role may be just what you’re looking for. You will be playing a key role in giving patients access to innovative technologies.-
- Key Responsibilities:- Coordinate implementation of Australia’s UDI (Unique Device Identification) requirements across all represented manufacturers and device categories.
- Gather, verify, and maintain UDI-related product data from overseas manufacturers in compliance with TGA’s AusUDI specifications.
- Track and manage timelines for UDI implementation by device class.
- Maintain ARTG documentation and ensure ongoing accuracy of product listings and manufacturer details.
- Support readiness for TGA inspections through accurate documentation.
- Track CAPA actions related to UDI or vigilance.- Experience & Qualifications:- Bachelor’s degree in Life Sciences, Biomedical Engineering or related field.
- 2-4 years’ experience in medical device regulatory or compliance administration.
- Understanding of TGA obligations including post-market and sponsor requirements.
- Knowledge of UDI principles and data management
- Collaborative and self-motivated and committed to continuous improvement- At EBOS MedTech, we value connection across teams, businesses, and borders. We share knowledge and build strong relationships to foster a supportive environment where every employee can grow and thrive.-
- If you’re commercially minded, purpose-driven, and ready to help shape the future of healthcare, this role offers a unique chance to make a meaningful difference.-
- and be part of EBOS MedTech that’s changing lives together, starting with you.

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