Regulatory Affairs Senior Specialist
The Sydney Regulatory Affairs team leads strategic and tactical regulatory initiatives for ResMed's core portfolio of Sydney-manufactured devices. As a key member of the team, you will drive global submission readiness, change assessments, and technical documentation that meet diverse market requirements.
Key Responsibilities:
- Author and review global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers for masks, CPAP devices, and ventilators.
- Interpret device-specific requirements (e.g., ISO 17510, ISO 80601, ISO 18562) and translate them into clear, 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 (e.g., 510(k), CE Marking, TGA ARTG).
- Strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations.
- Excellent communication, project planning, and cross-functional influence skills.