Manager, Regulatory Product Strategy

Manager, Regulatory Product Strategy & Delivery – Sydney. You will oversee regulatory execution for products manufactured under the ResMed Sydney legal entity. You'll lead a team responsible for shaping and delivering global regulatory strategies that span concept through launch and ensure successful navigation of global regulatory pathways.

• Strategic & Operational Leadership
• Lead RA strategy and delivery for NPI projects owned by Sydney
• PLE projects owned by the Sydney and Singapore legal manufacturer (e.g., masks, devices, accessories)
• Define regulatory pathways and ensure submission planning aligns with market access timelines and business needs
• Guide the development of design input requirements, verification strategies, and risk documentation that meet global regulatory expectations (e.g., 510(k), CE Mark, TGA, MDSAP)
• Escalate risks, resource constraints, or submission delays proactively and constructively, in line with the RA escalation model
• Cross-Functional Collaboration
• Support the team and be the RA representative on product XFTs originating from Sydney
• Drive alignment with key functions such as systems engineering, quality, project management, operations, clinical, and marketing
• Ensure early RA input and engagement during design reviews, change planning, and design control phases
• Regulatory Strategy & Submission Oversight
• Oversee the development and delivery of high-quality regulatory submissions globally, including US FDA, EU MDR, TGA, and other priority markets
• Review and approve key submission components and assessments, including Design Change Assessments (DCAs), risk-benefit documentation, and labelling claims
• Ensure documentation is submission-ready and aligned with ResMed\'s quality system, global templates, and timelines
• People Leadership & Team Development
• Lead and coach a team of regulatory professionals, supporting career development, onboarding, and performance management
• Foster a high-trust, inclusive culture that emphasizes accountability, regulatory excellence, and continuous learning
• Support Individual Development Plans, mentoring structures, and knowledge sharing within the team and the broader RA function
• Process Excellence & System Stewardship
• Drive improvements to regulatory workflows, including Jira tracking, RIMSYS submissions, and Confluence knowledge management
• Ensure the team uses consistent processes, applies global templates, and adheres to design control and submission SOPs
• Collaborate with the Regulatory Foundations and Digitalization teams to enhance submission logistics, tools, and dashboards

• Bachelor\'s degree (or higher) in biomedical engineering, life sciences, regulatory affairs, or a related discipline
• 6+ years in Regulatory Affairs, with 2+ years in a leadership or mentoring capacity
• Proven experience supporting device submissions (e.g., FDA 510(k), CE MDR, TGA ARTG)
• Excellent knowledge of ISO 13485, ISO 14971, 21 CFR 820, and other applicable standards
• Experience working on design and development teams under design control processes
• Strong organizational and time management skills; ability to lead multiple concurrent priorities
• Clear, structured communicator with experience influencing cross-functional partners and regulatory authorities

• Prior experience leading RA strategy for a legal manufacturer or global product line
• Experience with Jira, Confluence, and RIMSYS (or equivalent regulatory systems)
• Familiarity with digital health components (e.g., connectivity, software in devices)
• Project management certification or training

• You are a strategic operator and a team builder—a person who thrives on connecting the dots between business goals, product innovation, and regulatory pathways. You have deep RA knowledge and a practical sense for how to lead and deliver in cross-functional environments
• You bring confidence and clarity to complex regulatory decisions, and you create space for others to grow while maintaining a high bar for execution and integrity. You're excited to shape the next chapter of regulatory leadership at ResMed

Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now