Senior Regulatory Affairs for Medical Devices - EU MDR

AustCorp Executive; Sydney; Hybrid; AUD 130,000 - 150,000; Full time

Benefits offered by this job

Hybrid work arrangement

Up to 2 days WFH

Job summary

AustCorp Executive in Sydney is seeking a Senior Regulatory Affairs Specialist for medical devices to lead EU MDR compliance and regulatory strategy across international markets. The role collaborates with engineering and product development teams to ensure robust regulatory submissions and ongoing compliance.

You will engage with Notified Bodies, maintain technical documentation, and drive QA and QMS improvements in a hands-on, team-oriented environment within a smaller medical technology

Qualifications

• Proven Regulatory Affairs experience within the medical device industry.
• Hands-on EU MDR experience is essential.
• Experience supporting regulatory submissions and compliance activities.
• Knowledge of ISO 13485 and international medical device standards.

Responsibilities

• Manage regulatory activities in accordance with 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.
• Work closely with engineering and product development teams to assess regulatory requirements for changes and new technologies.
• Maintain compliance with international medical device standards and regulatory frameworks.
• Support post-market surveillance, vigilance reporting and ongoing regulatory obligations.
• Contribute to Quality Assurance activities, including QMS documentation and continuous improvement.
• Liaise with internal stakeholders and external regulatory bodies, including Notified Bodies.

Skills

Regulatory Affairs

EU MDR

Regulatory Submissions

Medical Device Regulations

Technical Documentation

ISO 13485

Collaboration

Proactive Attitude

Job description

AustCorp Executive in Sydney is seeking a Senior Regulatory Affairs Specialist for medical devices to lead EU MDR compliance and regulatory strategy across international markets. The role collaborates with engineering and product development teams to ensure robust regulatory submissions and ongoing compliance.

You will engage with Notified Bodies, maintain technical documentation, and drive QA and QMS improvements in a hands-on, team-oriented environment within a smaller medical technology