Project Specialist

Regulatory Project Coordinator

Sydney | Fully Remote | $95k + Super | 12‑Month Contract (Strong Renewal Pathway)

Ready to fast‑track your career in medical devices and regulatory affairs? This is a rare opportunity to step into a global organisation at the forefront of innovation, working directly with industry leaders on a multi‑year digital transformation programme.

This role is perfect for someone early in their career - a recent graduate or a candidate with 1–3 years’ experience - who wants to learn fast, gain international exposure, and build a long‑term pathway in regulatory operations.

Why This Opportunity Stands Out

You’ll be joining a high‑growth, medical device company with more than three decades of industry success. They’re known for their collaborative culture, flexible working, and a genuine “no‑ego” approach to leadership. Even before remote work became the norm, they embraced flexibility - and they continue to empower their teams to work in ways that support balance, autonomy, and high performance.

You’ll be supported by a highly respected APAC regulatory leader who believes in developing talent, leading from behind, and giving emerging professionals the space to shine. If you’re driven, curious, and eager to learn, you’ll thrive here.

The Role

As the Regulatory Project Coordinator, you’ll play a key role in a global initiative to implement an AI‑driven regulatory submission management platform - a project spanning APAC, Latin America, Europe, and beyond.

You’ll gain hands‑on experience across:

• Regulatory operations in APAC
• Project coordination and stakeholder management
• Digital transformation and system implementation
• Cross‑functional collaboration with global teams (US, Europe)

This is a unique blend of regulatory exposure and project management - ideal for someone who wants to build a strong foundation in both.

What You’ll Be Doing

• Coordinating the APAC contribution to a global AI platform rollout
• Supporting discovery workshops, vendor selection, and implementation planning
• Managing timelines, weekly meetings, and stakeholder communication
• Preparing monthly project updates and documentation
• Working closely with regulatory specialists across multiple regions
• Learning from an industry expert who will mentor and guide your development

You’ll be part of a tight‑knit Sydney‑based team that meets in person occasionally with day‑to‑day work done remotely.

Who This Suits

You don’t need years of experience - what matters most is your attitude.

You’ll thrive if you are:

• A recent graduate or early‑career professional (biomedical engineering, science, or similar)
• Highly organised, proactive, and eager to learn
• Interested in regulatory affairs and digital transformation
• Comfortable coordinating people, tasks, and timelines
• Tech‑savvy and confident with tools like Teams, Excel, and PowerPoint
• Someone who enjoys working with global teams and diverse cultures

If you’re the kind of person who wants to get stuck in, learn quickly, and make a real impact early in your career, this is the perfect launchpad.

Growth & Development

This isn’t a “coffee and admin” junior role. You’ll be trusted with meaningful work from day one and supported to grow into a full regulatory operations role over time.

You’ll also have opportunities to travel internationally (business class), attending APAC and global meetings - typically 1–3 trips per year.

The Offer

• $95k base + super
• Fully remote, with occasional meetups in Macquarie Park
• 12‑month contract with strong renewal and potential pathway to permanent
• Mentorship from a respected industry leader
• A genuinely supportive, high‑performing team culture

Contact Keeley Munday - [email protected]