APAC Regulatory Affairs Lead – Med Devices & Diagnostics

Abbott Laboratories; Sydney; On-site; AUD 90,000 - 150,000; Full time

Benefits offered by this job

Discounted Healthcare

Fitness Passport

Discounted Shares

Learning & Development

Onsite parking

Barista on site

Job summary

Abbott Laboratories in Sydney, NSW seeks an experienced Regulatory Affairs Manager to lead regulatory compliance across Australia, New Zealand and the Pacific Islands. Based in Macquarie Park, you will guide regulatory strategy, liaise with authorities, and support a diverse portfolio including infectious disease, cardiometabolic, and diagnostics products.

The role requires a BSc and at least 3 years in regulatory affairs within healthcare, with strong knowledge of the Australian TGA framework

Qualifications

• Bachelor degree required in a science-related field.
• Minimum 3 years in Regulatory Affairs within medical devices, diagnostics, or healthcare.
• Demonstrated experience with TGA Medical Device Regulatory Framework in Australia.

Responsibilities

• Lead regulatory submissions and registrations with authorities to ensure timely approvals.
• Maintain registrations and manage regulatory changes throughout product lifecycle.
• Oversee post-market surveillance including adverse event reporting and recalls.
• Review promotional materials for regulatory compliance.
• Coordinate import permits for biologicals and controlled substances when needed.
• Monitor regulatory developments impacting devices and related products.

Skills

Regulatory Affairs

Leadership

Project Management

Stakeholder Management

Analytical Thinking

Attention to Detail

Education

Bachelor of Science (BSc)

Job description

Abbott Laboratories in Sydney, NSW seeks an experienced Regulatory Affairs Manager to lead regulatory compliance across Australia, New Zealand and the Pacific Islands. Based in Macquarie Park, you will guide regulatory strategy, liaise with authorities, and support a diverse portfolio including infectious disease, cardiometabolic, and diagnostics products.

The role requires a BSc and at least 3 years in regulatory affairs within healthcare, with strong knowledge of the Australian TGA framework