Regulatory Affairs Lead for Global Supply Chain Projects

ResMed (Malaysia) Sdn Bhd (MY); Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

A medical technology company based in Singapore is seeking a Regulatory Affairs Senior Specialist to manage regulatory impacts across various Supply Chain projects. This role involves ensuring compliance with global regulations, driving documentation, and collaborating with cross-functional teams. Candidates should possess a bachelor's degree and over five years of experience in Regulatory Affairs or in the regulated medical device sector. This position also provides a clear pathway to leadership roles within regulatory operations.

Qualifications

• Minimum 5+ years of experience in Regulatory Affairs or regulated medical device environment.
• Proven experience in cross-functional project environments.
• Experience supporting global registrations and renewals, related to manufacturing transfers.

Responsibilities

• Lead as the primary RA resource within SC project teams.
• Drive regulatory assessment and documentation of manufacturing changes.
• Collaborate with teams to ensure regulatory compliance.

Skills

Global medical device regulations understanding

Document management proficiency

Regulatory change control knowledge

Strong written and verbal skills

Collaboration skills

Pragmatic problem-solving

Education

Bachelor in Life Sciences, Biomedical Engineering, Regulatory Affairs or related field

Tools

Document control systems

Regulatory databases (e.g. EUDAMED, FDA FURLS)

Job description

A medical technology company based in Singapore is seeking a Regulatory Affairs Senior Specialist to manage regulatory impacts across various Supply Chain projects. This role involves ensuring compliance with global regulations, driving documentation, and collaborating with cross-functional teams. Candidates should possess a bachelor's degree and over five years of experience in Regulatory Affairs or in the regulated medical device sector. This position also provides a clear pathway to leadership roles within regulatory operations.