Regulatory Affairs Manager

Thornton Tomasetti; Sydney; On-site; AUD 120,000 - 150,000; Full time

Benefits offered by this job

Discounted Healthcare Access toFitness

Discounted Shares program

Learning and development opportunities

Onsite parking and a barista

And Lots more…

Job summary

Abbott is seeking an experienced Regulatory Affairs Manager to lead regulatory compliance across Australia, New Zealand, and Pacific Islands. Based in Macquarie Park, NSW, you will be the regulatory expert and main liaison with authorities across infectious disease, cardiometabolic, informatics, and toxicology portfolios.

You will manage product registrations, stay ahead of regulatory changes, oversee post-market surveillance, and review materials for compliance while supporting clinical trials

Qualifications

• BSc or equivalent qualification is required.
• Minimum 3 years' experience in Regulatory Affairs within medical devices/diagnostics.
• Experience with Australian TGA Medical Device Regulatory Framework.

Responsibilities

• Manage product registrations and regulatory submissions with authorities.
• Maintain registrations and monitor regulatory changes across lifecycle.
• Lead post-market surveillance and adverse event reporting.
• Review promotional materials for regulatory compliance.
• Coordinate import permits and monitor regulatory developments.
• Serve as primary liaison with regulatory agencies and stakeholders.
• Support clinical trials by reviewing protocols and ethics submissions.
• Maintain regulatory databases and reporting processes.
• Provide regulatory guidance and training to internal teams.

Skills

Leadership

Analytical thinking

Regulatory interpretation

Regulatory project management

Communication & stakeholder management

Attention to detail

Independent work

QMS knowledge

Education

Bachelor of Science (BSc) or equivalent

Tools

Regulatory databases

Quality Management Systems (QMS)

Job description

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Our Rapid Diagnostics division is about providing innovative ways to screen, diagnose and monitor a vast range of health conditions with greater speed, accuracy and efficiency. Abbott’s rapid diagnostic tests allow healthcare professionals and their patients to get same-day results. For healthcare workers, this means they can diagnose and advise their patients in a single office visit. For patients, quicker results means earlier treatment, less anxiety, less time and money spent on repeat doctor visits and a faster return to good health.

The Role

We are seeking an experienced and motivated Regulatory Affairs Manager to lead regulatory compliance activities across our Australia, New 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 environment where innovation, continuous improvement, and professional growth are encouraged.

Benefits

• Discounted Healthcare Access to Fitness Passport
• Discounted Shares program
• Learning and development opportunities
• Onsite parking and a barista
• And Lots more…

The base pay for this position is N/A

In specific locations, the pay range may vary from the range posted.

Job Family: Regulatory

DIVISION: ID Infectious Disease

LOCATION: Australia > Macquarie Park : 299 Lane Cove Road

ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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