KLS Martin Group is a global leader in surgical innovation. Our Australian team is looking for a Regulatory Affairs Associate to support regulatory compliance and product registrations across our medical device portfolio.

This role is an opportunity to develop your career in regulatory affairs within an international medical technology company, working closely with local teams and our global headquarters.

As a Regulatory Affairs Associate, you will be responsible for:

- Preparing and maintaining regulatory documentation for medical devices
- Supporting TGA submissions, ARTG registrations, amendments, and ongoing compliance
- Maintaining accurate product records, technical documentation, and regulatory databases
- Assisting with regulatory assessments for current products and product changes
- Liaising with internal teams and international stakeholders to obtain required documentation
- Monitoring changes to Australian medical device regulations and standards
- Assisting with conformity assessment documentation and ensuring medical devices meet applicable Australian regulatory requirements.
- Supporting post-market surveillance, adverse event reporting, and product recalls
- Assisting with internal and external audits and regulatory inspections




- Supporting continuous improvement of regulatory processes and documentation

About You

- Tertiary qualification in Science, Biomedical Science, Engineering, Health Sciences, or a related field
- Strong attention to detail and organisational skills
- Excellent written and verbal communication skills
- Ability to manage multiple tasks and work independently
- Strong analytical and problem-solving abilities
- Proficiency in MS Office applications
- Understanding of regulatory compliance and documentation requirements
- Preferred: experience in medical devices, regulatory affairs, or quality assurance
- Preferred: familiarity with TGA, ARTG, ISO 13485, or medical device regulations
- Preferred: understanding of medical device conformity assessment procedures and regulatory pathways.

Why Join KLS Martin

KLS Martin is known worldwide for precision, innovation, and quality in surgical solutions. You'll be part of a globally recognised brand delivering life-changing patient outcomes through cutting-edge personalised implants and technologies.

Only candidates with full Australian working rights can be considered for this role.

We are interviewing immediately.

📌 Regulatory Affairs Associate (Sydney)
🏢 KLS Martin Australia
📍 Sydney