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Regulatory Affairs Expert
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This is a highly skilled and experienced Senior Specialist Regulatory Affairs role in Sydney, Australia. The successful candidate will have significant expertise in regulatory affairs within the medical devices industry, with a proven track record of leading global regulatory submissions.
Key Responsibilities:
- Author and review global regulatory submissions for medical devices, including FDA 510(k), CE Marking, TGA ARTG, and Health Canada dossiers;
- Interpret device-specific requirements, such as ISO 17510, ISO 80601, and translate them into clear and well-supported regulatory documentation;
- Align closely with Regional RA to ensure reusable, scalable submission approaches and consistent technical content;
Product Change & Lifecycle Support:
- Lead regulatory assessments of design and process changes, performing significance evaluations and preparing documentation updates;
- Provide regulatory input on system-level verification, biocompatibility, human factors, and labelling updates for high-volume products;
- Collaborate with Engineering and Quality to resolve submission blockers and maintain lifecycle documentation compliance;
Cross-Functional Integration & Design Control Support:
- Represent RA in cross-functional design teams for products under Sydney legal manufacturer scope;
- Engage early in project scoping and risk management activities to shape regulatory deliverables and timelines;
- Act as a key point of contact for internal stakeholders on Sydney product regulatory requirements and interpretations;
Mentorship & Peer Enablement:
- Mentor junior team members in regulatory interpretation, submission content quality, and cross-functional collaboration;
- Support onboarding and documentation standardization across the Sydney RPSD team;
- Contribute to process improvements and advocate best practices in tools like Jira, Confluence, and RIMSYS;
Qualifications & Experience:
- Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline;
- 5+ years of experience in Regulatory Affairs within a regulated industry (preferably medical devices);
- Proven experience leading or coordinating global regulatory submissions;
- Strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations;
Preferred Qualifications:
- Prior experience working with ResMed-type devices (CPAP, ventilators, masks, accessories);
- Familiarity with device-specific standards (e.g., ISO 17510, ISO , IEC 60601, ISO );
- Hands-on experience with submission platforms and document control tools (e.g., RIMSYS, Jira, Confluence);
- Experience providing peer review or coaching in a cross-regional or matrixed environment;
