Manager – APAC Regulatory and Market Access

Avania is adding to our dynamic, multi-disciplinary Regulatory and Advisory Services team. We are seeking an experienced regulatory professional with deep expertise in medical device regulatory strategy, particularly with the regulatory authorities in Australia and coordinating with our project teams in China, Japan, Korea, and EU and US global leaders. This is an individual contributor role for a regulatory expert who brings strategic insight, hands-on regulatory experience, APAC vendor management, and a proven ability to guide medical device companies through complex regulatory documentation projects.

As Manager, APAC Regulatory and Market Access, you will be Avania's regulatory and market access lead in Australia and the primary point of contact for clients across the region. The work is hands-on and documentation-led. You will own Australian TGA strategy and submissions, clinical trial documentation, and Australian market access support, while enabling and coordinating project teams and in-country partners across China, Japan, Korea, and New Zealand.

Day to day, this includes strategic input on ARTG inclusion and conformity assessment pathways, Comparable Overseas Regulator reliance routes, application audit responses for higher risk devices, Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) submissions with HREC and site governance coordination, TGA pre-submission meetings and technical consultations, and Priority Applicant Determination requests, all in support of large and complex medical device programs.

What you'll be doing:

• Serve as regulatory subject matter expert for Australian TGA submissions and documentation, including ARTG inclusion applications, conformity assessment evidence, Essential Principles mapping, and application audit responses.
• Prepare and manage clinical trial documentation for Australian and New Zealand studies, including CTN and CTA scheme submissions, HREC and research governance packages, and Australian sponsor obligations.
• Deliver regulatory strategy work: classification and rule determinations, pathway assessments, COR reliance analysis, TGA pre-submission meeting preparation, and Priority Applicant Determination requests.
• Support Australian market access engagements, including Prescribed List applications and MSAC and MBS pathway assessments, in partnership with our global market access team.
• Coordinate APAC programs across China, Japan, Korea, and New Zealand, working with in-country regulatory partners and taking accountability for the quality, consistency, and timeliness of their output.
• Select, brief, and manage regional vendors, local sponsors, and agents, including scope, budget, schedule, and technical review of every deliverable before it reaches a client.
• Write and quality control high quality regulatory, clinical, and market access documentation, and act as final reviewer on regional deliverables.
• Serve as the primary client contact for regional engagements, with clear, credible, and commercially minded communication.
• Partner with local business development on scoping conversations, proposals, and estimates, and contribute to thought leadership that raises Avania's profile across APAC.

This is an individual contributor role. The ideal candidate will have excellent hands-on prior experience working at the Australian TGA documentation for clinical trials and regulatory documentation, combined with an understanding of regulatory requirements across multiple global markets with a focus on China NMPA, Japan PMDA, Korea KFDA, and ability to work cross-functionally with EU/US global regulatory leaders. Experience working as a regulatory consultant or within a company developing a novel medical device is highly desirable.