Manager, Regulatory Product Strategy

Overview
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.
Key Responsibilities
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
Qualifications & Experience
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
Preferred
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
Who You Are
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
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