Are you an experienced Regulatory Affairs professional looking to take full ownership of a portfolio and make a massive impact in a diverse, growing environment? Our Regulatory Affairs Manager opportunity (Permanent Part-time) could be the perfect next step in your career, offering the autonomy to shape regulatory strategy and make a meaningful contribution to a growing Australian diagnostics business.

About Us
Southern Cross Diagnostics Pty Ltd is an established, Australian-based supplier and sponsor of TGA-regulated in vitro diagnostics (IVDs) and related medical devices. Based in Sydney, we are a close-knit, agile team operating in an entrepreneurial environment where your expertise directly drives company growth and improves patient outcomes. Here, you will lead our regulatory strategy from the front, collaborate daily with our on-site team, and play a pivotal role in bringing critical diagnostic products to the Australian healthcare market. The Opportunity This is a fantastic opportunity for an experienced senior specialist, or an ambitious specialist ready to take the next step in their career. Ideal for someone looking to move beyond the traditional multinational corporate environment, the role offers the opportunity to take on greater responsibility, influence key decisions and make a real impact. As our Regulatory Affairs Manager, you will take full accountability for our TGA portfolio with a hands-on strategic focus to maintain our high standards of compliance. You will manage the entire product lifecycle of our IVD and medical device portfolio, ensuring seamless market access. Based at our office in Banksmeadow, Sydney, and reporting directly to senior leadership, this high-visibility role is perfect for an autonomous expert who thrives on collaboration and values the energy of working closely with a local team.

Key Responsibilities
• TGA Submissions & Maintenance: Prepare, submit,



and manage IVD and medical device inclusion applications on the Australian Register of Therapeutic Goods (ARTG).
• Sponsorship Compliance: Act as the primary liaison with the TGA, overseas manufacturers, and internal sales/marketing teams, ensuring all Australian sponsor obligations consistently meet the highest standards.
• Compliance Strategy: Provide expert regulatory guidance on product development, labelling, and promotional materials to ensure alignment with Australian therapeutic goods regulations.
• Technical Documentation: Review and adapt overseas manufacturer technical files, labelling, and instructions for use (IFU) to comply with TGA frameworks.
• Post-Market Surveillance: Oversee adverse event reporting, product notifications, recalls, and mandatory sponsor reporting obligations.
• Document Control System: Maintain and improve the company’s document control systems in alignment with quality management best practices.
• Cross-Functional Collaboration: Provide immediate, expert regulatory guidance to our local sales, logistics, and management teams to streamline business decisions and upheld rigorous compliance requirements. What You Bring
• IVD & Medical Device Expertise: Minimum 5+ years of experience navigating TGA regulations with specific exposure to IVDs and related medical devices. Deep knowledge of EU IVDR transitions and evolving TGA reforms/guidance is essential.
• Hands-on TGA

Experience:




A strong track record of successful ARTG inclusions, a thorough understanding of the Therapeutic Goods Act and Medical Device Regulations, and proven skilled correspondence with the TGA.
• The Agile Mindset: An entrepreneurial, problem-solving mindset. You enjoy a small-business environment where you can seamlessly shift between high-level strategy and daily operational tasks.
• Communication

Skills:
Exceptional written and verbal communication skills, and impeccable attention-to-detail, with the ability to translate complex regulatory requirements into practical business strategies for local and international partners.
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Qualifications:
A tertiary degree in Science, Biomedical Engineering, Pharmacy, or a related field.
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Location:
Based in Sydney with the ability to work from our office, fostering strong relationships across the local business.

What We Offer
• Remuneration: Competitive salary package + superannuation + performance bonus.
• Work-Life Balance: True work-life balance with flexible hybrid working arrangements available for the right candidate.
• Role Ownership: A flat organizational structure where your voice is heard, decisions are made quickly, within a culture focused on streamlined processes.
• A Collaborative Culture: A dedicated Sydney team that values face-to-face collaboration and a supportive workplace community.
• Global Exposure: Opportunities to work directly with global manufacturing partners and actively shape our local product portfolio. To Apply If you are ready to own your regulatory space and grow alongside an ambitious local supplier and sponsor, we want to hear from you. Please click "Apply Now" to submit your resume and a brief cover letter outlining your offering and hands-on experience with TGA IVD and medical device regulations.

📌 Regulatory Affairs Manager (Sydney)
🏢 Southern Cross Diagnostics
📍 Sydney