About Atomo Diagnostics

Atomo Diagnostics is a global leader in rapid diagnostic solutions, committed to delivering innovative, user-friendly testing platforms that improve healthcare outcomes worldwide.

Role Summary

We are seeking an experienced Regulatory Affairs Specialist to join our Sydney team on a full-time, six-month fixed-term contract to provide parental leave cover. The role will support regulatory compliance and ongoing market access for in-vitro diagnostic (IVD) products across global markets, with particular focus on EU IVDR, and Australian Therapeutic Goods Regulations. This is a hands on role working closely with cross-functional teams across the product life cycle from product development and regulatory submissions through to post market activities and maintenance of existing approvals.

Key Responsibilities

Regulatory Planning & Submissions

- Support and execute regulatory strategies to enable timely product approvals and ongoing market access in global markets.
- Plan, coordinate, prepare, and maintain regulatory submissions and applications for authorities such as TGA, WHO, EU Notified Bodies (CE marking/IVDR), and applicable ISO certifications.
- Support timely regulatory authorisations, renewals, and variations.
- Maintain regulatory licences, product registrations, and approvals across jurisdictions.

Design & Development Support

- Establish and communicate applicable regulatory requirements during design and development activities.
- Participate in product development teams to support regulatory compliance and risk management.




- Provide timely review and approval of design, technical, and quality documentation to ensure regulatory readiness.

Post-Market Regulatory Support

- Support post-market regulatory activities for marketed products, including:
- Change management and regulatory impact assessments
- Regulatory notifications and variations
- Vigilance reporting, complaints, and adverse event reporting

Compliance & Quality Systems

- Ensure compliance with applicable regulations, standards, and quality systems, including ISO 13485, EU IVDR, EU MDR (where applicable, WHO PQ and Australian Therapeutic Goods Regulations.
- Support internal and external audits and inspections conducted by regulatory authorities and notified bodies.

Technical Documentation & Risk Management

- Review technical documentation and provide clear, practical feedback to cross-functional teams to promote regulatory compliance and inspection readiness.
- Identify, communicate, and contribute to the mitigation of regulatory risks throughout the product lifecycle.

Regulatory Processes & Intelligence

- Support the development, implementation, and maintenance of regulatory processes and procedures, including contribution to internal training.




- Conduct regulatory intelligence activities, including regulatory surveillance and monitoring of changes in global regulatory requirements, and communicate impacts internally.

About You

This role is ideal for a regulatory professional with experience in the IVD or medical device industry who enjoys working in a team-oriented, fast-paced environment. You are organised, detail-oriented, and able to translate complex regulatory requirements into clear, actionable guidance for stakeholders.

Key attributes include:

- Strong attention to detail and high-quality technical writing skills
- Ability to interpret and apply regulatory requirements pragmatically
- Effective written and verbal communication skills
- Ability to work independently while collaborating across functions
- Strong organisational and time-management skills
- Willingness and ability to learn and adapt in a changing regulatory environment

Qualifications & Experience

- Bachelor’s degree in Life Sciences, Medical Science, Biochemistry, Biomedical Engineering, or a related discipline.
- Minimum 5 years’ experience in regulatory affairs within the medical device or diagnostics (IVD) industry.
- Solid working knowledge of global regulatory frameworks, including EU IVDR/MDR, and TGA.
- Demonstrated experience supporting regulatory submissions and maintaining regulatory approvals.
- Strong communication, documentation, and coordination skills.

How to Apply

Please send your application to [email protected]

📌 Regulatory Affairs Specialist - 6-Month Fixed-Term Contract/Parental Leave Cover (Sydney)
🏢 Atomo Diagnostics
📍 Sydney