Regulatory Affairs Senior Specialist - Supply Chain Projects

Responsibilities

• Act as the primary regulatory lead for global and regional supply chain projects.
• Drive regulatory assessment and documentation for manufacturing changes and distribution requirements to ensure global compliance (e.g., US FDA, EU MDR, TGA).
• Collaborate with cross-functional teams including quality, manufacturing, engineering, and supply chain to resolve queries related to device changes and manufacturing transfers.
• Proactively identify and escalate regulatory risks linked to operational changes such as site transfers, packaging updates, or sourcing modifications.
• Monitor international regulatory changes related to medical device manufacturing and distribution and communicate updates to stakeholders.
• Provide regulatory documentation support for audits and inspections.
• Lead or support regulatory activities, including submissions and facility licenses, related to new sites or supply chain transformation projects.

Requirements

• Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
• Minimum 5+ years of experience in Regulatory Affairs or a regulated medical device environment.
• Proven experience in manufacturing, distribution, or regulatory operations.
• Foundational understanding of global medical device regulations, including 21 CFR820, EU MDR, and ISO 13485.
• Proficiency in using regulatory databases and document control systems (e.g., EUDAMED, FDA FURLS).
• Experience in cross-functional project environments, preferably with global exposure.

Preferred Qualifications

• Experience supporting global registrations or renewals related to manufacturing transfers or process changes.
• Specific experience or a strong interest in supply chain operations.

About the Company

ResMed creates life-changing health technologies that empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices, and intelligent software make home healthcare more personalized, accessible, and effective.