Regulatory Affairs Lead, APAC Medical Devices & Diagnostics

Abbott; Sydney; On-site; AUD 110,000 - 170,000; Full time

Benefits offered by this job

Discounted Healthcare

Fitness Passport access

Discounted Shares program

Learning and development opportunities

Onsite parking & barista

Job summary

Abbott in Sydney seeks an experienced Regulatory Affairs Manager to lead regulatory compliance across Australia, New Zealand and Pacific Islands. Based in Macquarie Park, you will act as the regulatory expert and primary liaison with authorities, supporting a diverse portfolio of diagnostic and medical products.

You will manage registrations, lifecycle changes, post-market surveillance, and review promotional materials for compliance.

Qualifications

• Bachelor of Science (BSc) or equivalent.
• Minimum 3 years' regulatory affairs experience in medical devices/diagnostics.
• Experience with Australian TGA Medical Device Regulatory Framework.
• Strong understanding of AU and NZ regulatory requirements.

Responsibilities

• Manage regulatory registrations and submissions with authorities.
• Maintain existing registrations and manage lifecycle changes.
• Lead post-market surveillance and adverse event reporting.
• Review promotional materials for regulatory compliance.
• Coordinate import permits for biological and controlled substances.
• Monitor regulatory developments impacting medical devices.
• Serve as primary liaison with regulatory agencies and stakeholders.
• Support clinical trials by reviewing protocols and ethics submissions.
• Maintain regulatory databases and tracking systems.
• Represent Abbott in industry associations and working groups.
• Provide regulatory guidance and training to internal teams.

Skills

Leadership

Regulatory affairs

Regulatory submissions

Stakeholder mgmt

Project mgmt

Analytical skills

Education

Bachelor of Science (BSc)

Job description

Abbott in Sydney seeks an experienced Regulatory Affairs Manager to lead regulatory compliance across Australia, New Zealand and Pacific Islands. Based in Macquarie Park, you will act as the regulatory expert and primary liaison with authorities, supporting a diverse portfolio of diagnostic and medical products.

You will manage registrations, lifecycle changes, post-market surveillance, and review promotional materials for compliance.