| Regulatory Policy & Strategic Planning Manager |
Vacancy Listing Dates 15/10/2026 to 12/11/2026
Please Quote Reference Number 18928 |
| Full time permanent position |
| $90,000 - $110,000 AUD per annum + Superannuation |
| Located in Adelaide, Australia |
About Us
Ominro Australia Pty Ltd is an innovative, newly established medical device import, supply chain, and distribution enterprise initiating operations from our corporate headquarters in Adelaide. As we establish our footprint as a legal Sponsor of advanced therapeutic goods under the Therapeutic Goods Administration (TGA), our mission is to introduce cutting-edge global medical technologies to the Australian healthcare sector.
To build our regulatory foundation and spearhead our market entry, we are seeking an exceptional Regulatory Policy & Strategic Planning Manager.
Role Purpose
As a foundational executive hire reporting directly to the Managing Director, you will play a critical role in launching our business operations. You will be entirely responsible for designing, implementing, and governing our corporate policy frameworks from the ground up, ensuring absolute compliance with the Therapeutic Goods Act 1989 and ISO 13485 standards. You will simultaneously architect the company's initial commercial market access strategy, establishing the pipelines that allow our imported medical technologies to clear regulatory hurdles and enter the domestic market.
Core Duties & Responsibilities:- Policy Creation & Governance: Build, author, and enforce the company's initial internal Quality Management System (QMS) policies, post-market surveillance protocols, and adverse event reporting frameworks in strict alignment with TGA guidelines.
- Strategic Launch & Market Entry Planning: Conduct comprehensive short and long-term business planning to assess the technical and financial feasibility of our initial medical device portfolios.
- Government & Stakeholder Liaison: Act as the primary corporate representative to establish our brands with regulatory bodies, leading initial consultations with the TGA, healthcare procurement networks, and international manufacturing partners.
- Policy Research & Risk Analysis: Perform continuous research and analysis on shifting Commonwealth healthcare funding and clinical evidence rules to safeguard our start-up operations from compliance bottlenecks.
- Accountability & Audit Frameworks: Establish risk-planning schedules and metrics to audit overseas manufacturer data (including CE certifications and sterilization validation files) prior to Australian registry.
- Commercial Negotiation: Represent our newly formed business entity at high-level corporate forums, clinical panels, and during complex international distribution contract negotiations.
Qualifications & Experience Requirements:- A Bachelor's degree or higher qualification in Health Policy, Business Administration, Corporate Law, Biomedical Engineering, or a strictly relevant discipline.
- A minimum of 5 years of highly relevant professional experience within medical device regulatory affairs, healthcare policy management, or corporate medical supply chain planning.
- Deep, authoritative knowledge of the Australian Register of Therapeutic Goods (ARTG) framework or similar framework experience with World Health Organization (WHO) audited country , risk classification guidelines, and international conformity pathways.
- A proactive, start-up mindset with a proven track record of building compliance policies and managing high-stakes stakeholder or government relationships from scratch.
A remuneration package between $90,000 - $110,000 + super will be offered to the successful candidate.
APPLY NOW through our online application form.
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| Please Quote Reference Number 18928 |
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