Avania are Hiring - Manager - APAC Regulatory and Market Access (Australia Based)
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 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.
About the role
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 a 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.
Candidates who offer any combination of the skills, knowledge and experience listed below, are encouraged to apply for the role of Manager - APAC Regulatory and Market Access
What we're looking for
Comfortable and confident in client-facing roles, able to act as a trusted subject matter expert on regulatory strategy and pathways to market for global sponsors.
Excellent regulatory and quality technical writing, including submissions, clinical trial documentation, and market access dossiers. Writing quality is the core of this role, not an adjacent skill.
Strong project and vendor management, with demonstrated experience holding external partners to scope, budget, and quality standards.
Proven ability to work autonomously across time zones, set priorities independently, and escalate early rather than late.
Professional proficiency in Mandarin or Japanese alongside excellent written English is a significant advantage, given the volume of primary regulatory source material, agency correspondence, and partner communication conducted in those languages.
Experience in device regulatory consulting, with cardiovascular, neurology, or orthopedic experience considered a strong advantage.
Flexibility to manage multiple concurrent engagements, from deeply involved strategic programs to lighter touch advisory support.
Strong analytical judgment: the ability to interpret complex regulatory and clinical issues, assess benefit and risk, and give clients a clear recommendation rather than a list of options.
Willingness to be actively involved in business development, supporting sales cycles for both clinical trials and advisory services.
What you'll need
Demonstrated hands-on experience preparing regulatory or quality technical documentation for the TGA. Examples include ARTG inclusion and conformity assessment dossiers, CTN or CTA packages, or application audit responses.
Working knowledge of the Australian framework: the Therapeutic Goods Act and Medical Devices Regulations, Essential Principles, classification rules, Australian sponsor obligations, and the TGA framework for software based medical devices.
Familiarity with at least one additional APAC framework (China NMPA, Japan PMDA, Korea MFDS, or New Zealand Medsafe WAND notification) and the appetite to build depth across the region.
Project and vendor management experience in a regulated environment. ISO 13485 and MDSAP familiarity is helpful.
Familiarity with FDA and EU MDR requirements is an advantage, since most of our clients are running Australia as one leg of a global program.
Ability to communicate effectively and confidently with sponsors, internal delivery teams, and senior leadership.
A degree in a scientific, clinical, regulatory, or engineering field, or equivalent experience.
Current and unrestricted right to work in Australia.
What we offer
We offer a dynamic and supportive work environment within a growing team focused on impactful regulatory and advisory projects for medical devices. You will have the opportunity to collaborate closely with cross-functional teams including clinical, regulatory, and commercial/business development, enhancing your professional development and market visibility. We provide a clear and structured interview process, competitive compensation, and the potential for career growth within our expanding global regulatory advisory group. Join us to shape pathway-to-market strategies, contribute to meaningful client engagements, and advance your expertise in a company committed to your success.
We look forward to receiving your application
Avania - MedTech's trusted Champion
LI-DNI
