Regulatory Affairs Lead - Medical Devices (EU MDR, Hybrid)

Austcorp; Sydney; Hybrid; AUD 130,000 - 150,000; Full time

Benefits offered by this job

Hybrid work up to 2 days

Permanent full-time with flexibility

Exposure to orthopaedic medical tech

Job summary

AustCorp Executive is seeking a Senior Quality & Regulatory Affairs Specialist to drive regulatory activities for innovative orthopaedic medical devices. The role combines hands-on EU MDR work with collaboration across engineering and product teams in a hybrid Sydney setting.

Ideal candidates will have proven medical device regulatory experience, EU MDR expertise, and familiarity with ISO 13485. The position offers a permanent full-time arrangement with part-time flexibility and a hybrid work

Qualifications

• Proven Regulatory Affairs experience in medical devices.
• Hands-on EU MDR experience is essential.
• Experience supporting or managing regulatory submissions and compliance activities.
• Knowledge of international medical device regulations including TGA and FDA requirements.
• Experience working with medical device technical documentation.
• Familiarity with ISO 13485 and related medical device quality standards.
• Ability to collaborate with engineering, quality and product teams.
• Proactive, adaptable, and able to manage a broad range of regulatory responsibilities.

Responsibilities

• Manage and support regulatory activities per EU MDR, TGA and FDA requirements.
• Prepare, review and maintain regulatory submissions and technical documentation.
• Support regulatory compliance for medical device hardware and software products.
• Collaborate with engineering and product teams to assess regulatory requirements for changes and new tech.
• Maintain compliance with international medical device standards and regulatory frameworks.
• Support post-market surveillance, vigilance reporting and ongoing regulatory obligations.
• Contribute to QMS documentation and continuous improvement.
• Liaise with stakeholders and Notified Bodies when required.

Skills

Regulatory affairs

EU MDR

Regulatory submissions

Medical devices

TGA/FDA knowledge

Job description

AustCorp Executive is seeking a Senior Quality & Regulatory Affairs Specialist to drive regulatory activities for innovative orthopaedic medical devices. The role combines hands-on EU MDR work with collaboration across engineering and product teams in a hybrid Sydney setting.

Ideal candidates will have proven medical device regulatory experience, EU MDR expertise, and familiarity with ISO 13485. The position offers a permanent full-time arrangement with part-time flexibility and a hybrid work