Global Regulatory Affairs Leader — Supply Chain Projects

ResMed (Malaysia) Sdn Bhd (MY); Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

ResMed is seeking a Regulatory Affairs Senior Specialist to lead regulatory assessment for supply chain projects across regions, acting as primary RA resource within SC project teams and partnering with QARA, Operations and global RA. You will navigate lifecycle changes and ensure regulatory compliance.

This role offers exposure to international regulations (FDA, EU MDR, TGA, etc.), opportunities for leadership in regulatory operations or strategy, and a dynamic, cross-time-zone environment that

Qualifications

• Bachelor's degree or equivalent in Life Sciences, Biomedical Engineering, Regulatory Affairs or related field.
• 5+ years of experience in Regulatory Affairs in a regulated medical device environment.
• Experience with global registrations/ renewals and manufacturing transfers.
• Cross-functional, global exposure preferred.

Responsibilities

• Lead as the primary RA resource within SC project teams.
• Drive regulatory assessment and documentation of manufacturing changes and distribution requirements, ensuring global regulatory compliance (e.g. FDA, EU MDR).
• Collaborate with cross-functional teams such as quality, manufacturing, engineering, SC, and RA leads to gather input and resolve queries.
• Contribute to regulatory planning, risk assessments, and documentation during product & process changes and SC transformation projects.
• Identify regulatory risks and ensure early alignment with RA teams.

Skills

Regulatory Affairs

Global Regulatory Experience

Cross-functional Collaboration

Documentation & Change Control

Audits & Inspections

Education

Bachelor's degree in Life Sciences or Regulatory Affairs

Tools

EUDAMED

FDA FURLS

Document Control Systems

Job description

ResMed is seeking a Regulatory Affairs Senior Specialist to lead regulatory assessment for supply chain projects across regions, acting as primary RA resource within SC project teams and partnering with QARA, Operations and global RA. You will navigate lifecycle changes and ensure regulatory compliance.

This role offers exposure to international regulations (FDA, EU MDR, TGA, etc.), opportunities for leadership in regulatory operations or strategy, and a dynamic, cross-time-zone environment that