Manager, Regulatory Product Strategy

**About ResMed**

At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and patient trust are at the heart of our innovation.

Regulatory Affairs (RA) at ResMed is central to ensuring timely and compliant access to global markets. We work across more than 140 countries to deliver safe and effective innovations that improve quality of life. With global reach, deep technical knowledge, and strong regulatory partnerships, we lead with integrity and clarity to shape the future of health technology.

**Team Overview: Regulatory Product Strategy & Delivery (RPSD)**

The Sydney RPSD team is responsible for Regulatory Affairs leadership for product development projects where Sydney is the legal manufacturer. This includes both New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) projects across masks, therapy devices, and their accessories.

Operating as a vertical team within the broader RPSD function, the Sydney team collaborates with global stakeholders to define and execute regulatory strategies, deliver submission-ready documentation, and enable cross-regional compliance.

This role leads a team of regulatory professionals and works closely with engineering, project management, quality, and global RA partners.

**Position Summary**

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.

You will be accountable for team performance, resource allocation, regulatory input into cross-functional design activities, and timely submissions across markets.

**Key Responsibilities**

**1. 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.

**2. 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.

**3. 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.

**4. 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.

**5. 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**

**Required**
- 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 mul