Shape the future of a global medical devices innovator. Join a business that's investing in people, innovation, and local capability!

• Global medtech company with a fast-growing footprint in ANZ
• Recent high-impact acquisitions driving high-quality product innovation
• Step-change opportunity to lead and shape local regulatory strategy

We have the privilege of collaborating with this leading global medical technology organisation on a mission to become one of the top medical device companies worldwide. With a focus on a broad range of products, their portfolio includes trusted, high-quality brands that are well-established in the market.

 

Headquartered in Sydney, and supported by a strong global network, the company has continued to expand its presence through acquisitions with more growth ahead. The culture is high-performing, collaborative, and innovative. The team thrives on autonomy, is driven by patient impact, and is looking for someone with a growth mindset and desire to contribute meaningfully to a business that’s scaling with purpose. For this reason we are looking for a Regulatory Affairs Manager to join their team as the team grows with new product launches to come.

 

Reporting directly to the VP of Regulatory Affairs, you’ll take full ownership of regulatory activities in Australia and New Zealand. This is a newly created role, offering the chance to bring new innovative strategy.

 

Key responsibilities include:

• Lead regulatory strategy and operations across ANZ
• Manage a local specialist and coordinate with global teams
• Collaborate closely with R&D on product development and system innovation
• Drive regulatory processes for product launch and post-launch activities
• Manage licence applications and ensure local compliance
• Support broader regulatory improvement initiatives across the region

 

To be successful in this role you will have:

 

• Tertiary qualification (Degree or higher)
• Extensive experience in the medical devices industry across all product classes, with a strong understanding of regulatory frameworks in Australia and New Zealand (essential)
• Experience leading direct reports within regulatory affairs, providing guidance and leadership on regulatory issues (essential)
• Proven track record in product launches and pre-launch activities, working closely with R&D departments

 

If you're ready to take on a leadership role in a business that values innovation, collaboration and continuous growth this is your moment. You’ll play a key role in shaping the next chapter of local success while being backed by a highly engaged global team. The team is highly collaborative and accountable, in fact they trust their employees and offer high flexible hours encouraging ownership and proactiveness. This role is ideal for a self-starter who’s ready to lead, grow a team, and bring their strategic insight to a business undergoing exciting transformation.

 

To apply for this role please submit your application in WORD format by clicking  'apply'; or contact Jasmine Garbino on 0460947804 for further enquiries. Confidentiality is assured.