Reg Affairs, Quality and Reimbursement Officer, NSW
Sector
RAQA
Type
Permanent
Contact
edward.gallagher@onemd.com.au
Posted on
29-Jan-2026
Job Description
Regulatory Affairs, Quality & Reimbursement Officer (12 month FT Contract)
Medical Devices | Sydney |
About the Job
This is a pivotal, hands-on role for a Regulatory & Quality professional who wants real accountability for market access, compliance, and quality outcomes.
The client operates in a highly regulated, technically complex segment of the medical device market. As the local Regulatory, Quality & Reimbursement Officer reporting directly to the Managing Director you’ll be the go-to expert for Australia, ensuring products move efficiently from global pipeline to compliant market release while maintaining the highest quality standards post-market.
If you enjoy working at the intersection of regulation, quality systems, product change, and commercial reality, this role gives you the autonomy and trust to make a genuine impact.
The Opportunity
What You’ll Be Responsible For
The position has a strong generalist focus, centred on the day-to-day management and upkeep of regulatory, quality and reimbursement activities. It is well suited to an experienced Senior Associate or Officer, or a Junior Manager looking to broaden their scope across the full product lifecycle within a regulated medical device environment.
Key elements of the role include:
What We’re Looking For
Additional Requirements
Due to the nature of this role and access to medical facilities, up-to-date COVID-19 vaccination is required in line with state health orders.
Interested?
If you’re an experienced Regulatory & Quality professional looking to own the Australian regulatory landscape within a technically sophisticated medical device business, this role offers genuine scope & autonomy.
For a confidential discussion, contact Edward Gallagher at OneMD.
edward.gallagher@onemd.com.au
Medical Devices | Sydney |
About the Job
This is a pivotal, hands-on role for a Regulatory & Quality professional who wants real accountability for market access, compliance, and quality outcomes.
The client operates in a highly regulated, technically complex segment of the medical device market. As the local Regulatory, Quality & Reimbursement Officer reporting directly to the Managing Director you’ll be the go-to expert for Australia, ensuring products move efficiently from global pipeline to compliant market release while maintaining the highest quality standards post-market.
If you enjoy working at the intersection of regulation, quality systems, product change, and commercial reality, this role gives you the autonomy and trust to make a genuine impact.
- Be the local regulatory and quality authority for a respected global medical device manufacturer
- Own TGA submissions, compliance strategy, and quality systems for the Australian market
- Partner closely with global RA/QA teams, product management, and leadership
- Work in a business that values precision, accountability, and long-term thinking
The position has a strong generalist focus, centred on the day-to-day management and upkeep of regulatory, quality and reimbursement activities. It is well suited to an experienced Senior Associate or Officer, or a Junior Manager looking to broaden their scope across the full product lifecycle within a regulated medical device environment.
Key elements of the role include:
- Managing routine and ongoing Regulatory Affairs submissions and maintenance activities
- Maintaining effective working relationships with regulatory authorities and governing bodies
- Coordinating regulatory and quality inputs into RFP and tender submissions for the Australian market
- Managing and maintaining relevant regulatory portals and databases
- Acting as a key local interface between Australian operations and global regulatory, quality and product teams
- Supporting the Marketing team with rebate and reimbursement code changes
- Providing regulatory, quality and reimbursement input to support business-as-usual operations
- Significant experience within the medical device industry across Regulatory Affairs, Quality and/or Reimbursement
- Hands-on experience working with ISO 9001–certified Quality Management Systems
- Strong understanding of TGA requirements, medical device lifecycles pre and post market and design control
- Proven technical and regulatory writing capability
- Ability to manage multiple priorities with precision and autonomy
- Strong influencing, communication and stakeholder management skills
- High attention to detail with a practical, solutions-focused mindset
- Bachelor’s degree in a scientific discipline (or equivalent); RA/QA qualifications advantageous
Due to the nature of this role and access to medical facilities, up-to-date COVID-19 vaccination is required in line with state health orders.
If you’re an experienced Regulatory & Quality professional looking to own the Australian regulatory landscape within a technically sophisticated medical device business, this role offers genuine scope & autonomy.
For a confidential discussion, contact Edward Gallagher at OneMD.
edward.gallagher@onemd.com.au
