Job Description

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 n

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 n

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- Support and execute regulatory strategies to enable timely product approvals and ongoing market access in global markets.
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- 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.
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- Support timely regulatory authorisations, renewals, and variations.
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- Maintain regulatory licences, product registrations, and approvals across jurisdictions.
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Design & Development Support nn
- Establish and communicate applicable regulatory requirements during design and development activities.
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- Participate in product development teams to support regulatory compliance and risk management.
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- Provide timely review and approval of design, technical, and quality documentation to ensure regulatory readiness.
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Post-Market Regulatory Support nn
- Support post-market regulatory activities for marketed products, including: n n
- Change management and regulatory impact assessments
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- Regulatory notifications and variations
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- Vigilance reporting, complaints, and adverse event reporting
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Compliance & Quality Systems nn
- 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.
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- Support internal and external audits and inspections conducted by regulatory authorities and notified bodies.
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Technical Documentation & Risk Management nn
- Review technical documentation and provide clear, practical feedback to cross-functional teams to promote regulatory compliance and inspection readiness.
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- Identify, communicate, and contribute to the mitigation of regulatory risks throughout the product lifecycle.
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- Support the development, implementation, and maintenance of regulatory processes and procedures, including contribution to internal training.
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- Conduct regulatory intelligence activities, including regulatory surveillance and monitoring of changes in global regulatory requirements, and communicate impacts internally.
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About You n

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

Key attributes include: n

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- Strong attention to detail and high-quality technical writing skills
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- Ability to interpret and apply regulatory requirements pragmatically
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- Effective written and verbal communication skills
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- Ability to work independently while collaborating across functions
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- Strong organisational and time-management skills
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- Willingness and ability to learn and adapt in a changing regulatory environment
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Qualifications & Experience nn
- Bachelor’s degree in Life Sciences, Medical Science, Biochemistry, Biomedical Engineering, or a related discipline.
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- Minimum 5 years’ experience in regulatory affairs within the medical device or diagnostics (IVD) industry.
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- Solid working knowledge of global regulatory frameworks, including EU IVDR/MDR, and TGA.
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- Demonstrated experience supporting regulatory submissions and maintaining regulatory approvals.
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- Strong communication, documentation, and coordination skills.
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📌 Regulatory Affairs Specialist - 6-Month Fixed-Term Contract/Parental Leave Cover (Sydney)
🏢 Atomo Diagnostics
📍 Sydney