Senior Quality & Regulatory Affairs Specialist | Medical Devices

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 skilled seeking a part-time arrangement of 3-4 days per week.

The Prospect

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.

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 robust, 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 frame

📌 Senior Quality (Australia)
🏢 Austcorp Executive
📍 Australia