We are seeking an experienced and motivated Regulatory Affairs Manager to lead regulatory compliance activities across our Australia, Recent Zealand, and Pacific Islands business. This is an exciting opportunity to play a critical role in bringing innovative healthcare solutions to market while ensuring compliance with applicable regulatory requirements.

Based in Macquarie Park, NSW and reporting to the Director Regulatory Affairs APAC, you will act as the key regulatory expert and primary liaison with regulatory authorities, supporting a diverse portfolio across Infectious Disease, Cardiometabolic, Informatics, and Toxicology products.

Key responsibilities

- Manage product registrations and regulatory submissions with relevant authorities, ensuring compliance and timely approvals.
- Maintain existing product registrations and manage regulatory changes throughout the product lifecycle.
- Lead post-market surveillance activities, including adverse event reporting, recalls, and field safety actions.
- Review and approve promotional and external communication materials to ensure regulatory compliance.
- Manage biological and controlled substance import permits where required.
- Monitor and interpret regulatory developments impacting medical devices and related healthcare products.
- Serve as the primary point of contact for regulatory agencies and external stakeholders.
- Support clinical trials by reviewing protocols, assisting with ethics submissions, and coordinating sponsorship requirements.
- Maintain regulatory databases and tracking systems to support compliance and reporting activities.
- Contribute to industry consultations and represent the organisation within relevant industry associations and working groups.
- Provide regulatory guidance, support, and training to internal stakeholders across the business.

What we’re looking for

To be successful in this role, you will have:

Essential Qualifications & Experience





- 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 working with the Australian Therapeutic Goods Administration (TGA) Medical Device Regulatory Framework.
- Strong understanding of regulatory requirements across Australia and New Zealand.

Key Skills & Attributes

- Strong leadership and influencing capabilities.
- Excellent analytical and problem‑solving skills.
- Ability to interpret and apply complex regulatory requirements.
- High level of attention to detail and commitment to quality.
- Strong project management and organisational skills.
- Excellent communication and stakeholder management abilities.
- Ability to work independently while managing multiple priorities.
- Knowledge of Quality Management Systems and regulatory compliance frameworks.
- High levels of integrity, professionalism, and confidentiality.

Why Abbott?

At Abbott, you’ll be part of a purpose‑driven organisation focused on helping people live healthier lives. You’ll work with passionate and talented colleagues in a collaborative setting where innovation, continuous improvement, and professional growth are encouraged.

We also provide some fantastic advantages for our employees such as:

- Discounted Healthcare
- Access to Fitness Passport
- Discounted Shares program
- Learning and development opportunities
- Onsite parking and a barista
- And lots more

Equal Opportunity Employment

Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call or email.

Applications

To apply, submit your CV and a short introduction outlining your relevant sales and business development experience.

Other Instructions

When applying for this role, you must hold Australian working rights.

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