Senior Quality & Regulatory Affairs Specialist | Medical Devices

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

Senior Quality & Regulatory Affairs Specialist | Medical Devices

Location: Surry Hills Sydney

Salary: $130,000-$150,000 + Superannuation

Employment: Permanent Full-Time | Part-Time Considered

Hybrid: Up to 2 Days WFH Following Initial Onboarding

An Exciting Opportunity in Innovative Medical Technology

An exciting opportunity has become available for an experienced Senior Regulatory Affairs Specialist to join an innovative Australian medical technology company developing advanced solutions for the orthopaedic surgical industry.

This is a fantastic opportunity for a regulatory professional who enjoys working in a smaller, collaborative environment where they can make a genuine impact, take ownership of regulatory activities and work closely with engineering and product development teams.

The business is seeking a technically strong, hands-on regulatory professional with demonstrated EU MDR experience and a background in medical devices.

While full-time employment is preferred, the business is also open to considering an experienced professional seeking a part-time arrangement of 3-4 days per week.

The Opportunity

Working closely with the Quality and Regulatory leadership team, you will play an integral role in maintaining regulatory compliance, supporting product development and managing regulatory activities across international markets.

This is a varied, hands-on position offering exposure to both medical device hardware and software, with opportunities to contribute directly to regulatory strategy and product development.

Key Responsibilities

• Manage and support 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 associated with product changes and new technologies.
• Maintain compliance with relevant 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, compliance and continuous improvement.
• Liaise with internal stakeholders and external regulatory bodies, including Notified Bodies where required.
• Provide practical regulatory guidance to ensure compliance throughout the product lifecycle.

About You

We are looking for a technically capable regulatory professional who enjoys being hands-on and taking ownership of their work.

To be successful, you will ideally have

• Proven Regulatory Affairs experience within the medical device industry.
• Hands-on EU MDR experience - essential.
• Experience supporting or managing regulatory submissions and compliance activities.
• Knowledge of international medical device regulations, including TGA and ideally FDA requirements.
• Experience working with medical device technical documentation.
• Familiarity with ISO 13485 and relevant medical device quality standards.
• Ability to collaborate effectively with engineering, quality and product development teams.
• A proactive, adaptable approach and the confidence to manage a broad range of regulatory responsibilities.

Highly Regarded

• Experience with orthopaedic, surgical or software-based medical devices.
• Direct experience with FDA submissions and regulatory processes.
• Experience preparing technical documentation and responding to Notified Body questions.
• Exposure to both Regulatory Affairs and Quality Assurance.
• Previous experience working within a smaller medical technology company.

Please note: Candidates must have regulatory experience with medical devices. Pharmaceutical-only or IVD-only backgrounds will not be suitable for this opportunity.

What's on Offer?

• Competitive salary of $130,000-$150,000 + superannuation, depending on experience.
• Permanent full-time opportunity, with part-time flexibility for the right candidate.
• Hybrid working arrangements, with up to two days working from home once established in the role.
• Opportunity to work with innovative orthopaedic medical technologies.
• Broad exposure to international regulatory requirements and product development.
• Work closely with experienced leadership and highly skilled engineering teams.
• Genuine opportunity to take ownership, contribute ideas and influence regulatory processes.
• Supportive, collaborative and technically focused working environment.

Interested?

If you're an experienced Regulatory Affairs professional with hands-on EU MDR experience and are looking for an opportunity to have a genuine impact within an innovative medical technology business, we'd love to hear from you.