APAC Regulatory Affairs Manager - Medical Devices

Byd Australia; Sydney; On-site; AUD 130,000 - 180,000; Full time

Benefits offered by this job

Discounted Healthcare

Access to Fitness Passport

Discounted Shares program

Learning and development opportunities

Onsite parking and a barista

And lots more

Job summary

Abbott seeks an experienced Regulatory Affairs Manager to lead regulatory compliance activities across Australia, New Zealand and the Pacific Islands. Based in Macquarie Park, NSW, you will be the regulatory expert and liaison with authorities, supporting a diverse portfolio including Infectious Disease, Cardiometabolic, Informatics and Toxicology products.

You will manage registrations and submissions, oversee post‑market surveillance, review promotional materials, and provide regulatory

Qualifications

• Bachelor of Science (BSc) or equivalent qualification.
• Minimum 3 years’ experience in a Regulatory Affairs role within the medical device, diagnostics, healthcare, or related industry.
• Demonstrated experience with the Australian Therapeutic Goods Administration (TGA) Medical Device Regulatory Framework.

Responsibilities

• Manage product registrations and regulatory submissions with relevant authorities.
• Maintain existing registrations and manage regulatory changes through the lifecycle.
• Lead post-market surveillance, including adverse event reporting and recalls.
• Review promotional materials for regulatory compliance.
• Manage import permits for biological and controlled substances.
• Monitor regulatory developments affecting medical devices and healthcare products.
• Serve as primary contact for regulatory agencies and stakeholders.
• Support clinical trials by reviewing protocols and ethics submissions.
• Maintain regulatory databases and reporting systems.
• Represent the organisation in industry associations and working groups.
• Provide regulatory guidance and training to internal teams.

Skills

Leadership

Analytical thinking

Regulatory strategy

Stakeholder management

Regulatory writing

Education

BSc or equivalent

Job description

Abbott seeks an experienced Regulatory Affairs Manager to lead regulatory compliance activities across Australia, New Zealand and the Pacific Islands. Based in Macquarie Park, NSW, you will be the regulatory expert and liaison with authorities, supporting a diverse portfolio including Infectious Disease, Cardiometabolic, Informatics and Toxicology products.

You will manage registrations and submissions, oversee post‑market surveillance, review promotional materials, and provide regulatory