Regulatory Affairs Manager

Job description

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. We also provide some fantastic benefits 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… The base pay for this position is N/AIn 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)