Regulatory Strategy Lead – Americas & ANZ

ResMed; Sydney; Hybrid; AUD 120,000 - 180,000; Full time

Job summary

ResMed in Sydney is seeking a Regulatory Affairs Specialist – Americas & ANZ to lead regulatory strategies for a broad portfolio, including software as a medical device. You will manage registrations, submissions, and post-market activities across ANZ and the Americas, collaborating with QA, Product Marketing, Revenue and Supply Chain.

You will mentor peers, influence stakeholders in a matrixed global organization, and stay current with regulatory changes to drive timely approvals and compliant

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline, or equivalent experience.
• 6–8 years of regulatory experience in medical devices or pharmaceuticals, ANZ region.
• Desirable: entity licensing for import/distribution of health products.
• Strong English communication and stakeholder collaboration skills.
• Knowledge of ISO 13485, ISO 14971, design controls, and post-market surveillance.
• Experience with software-based medical devices or connected health products.
• RAC certification or progress toward it preferred.
• Experience in matrixed global organizations and influencing stakeholders.
• Creative, detail-oriented, highly organized, and able to multitask.

Responsibilities

• Provide regulatory strategies and deliverables for ANZ and Americas, coordinating with product development, clinical, marketing, and commercial teams.
• Prepare and compile premarket registrations for ANZ and Americas, and monitor post-market compliance for existing ResMed products including software as a medical device.
• Maintain regulatory records: submission docs, country registrations, import/export filings, etc.
• Support initiatives related to regional entity creations (including eCommerce).
• Communicate regulatory plans and timelines to internal and external partners, ensuring alignment with regulatory strategy.
• Monitor external standards and regulatory developments that impact the business and share with global teams.
• Share timely regulatory solutions to the global network for significant regulation changes.
• Pursue ongoing regulatory knowledge for product submissions and policy applicability to medical devices.

Skills

Interpersonal communication

English proficiency

Stakeholder collaboration

Regulatory strategy

Education

Bachelor's degree or higher in Life Sciences/Engineering

Job description

ResMed in Sydney is seeking a Regulatory Affairs Specialist – Americas & ANZ to lead regulatory strategies for a broad portfolio, including software as a medical device. You will manage registrations, submissions, and post-market activities across ANZ and the Americas, collaborating with QA, Product Marketing, Revenue and Supply Chain.

You will mentor peers, influence stakeholders in a matrixed global organization, and stay current with regulatory changes to drive timely approvals and compliant