Regulatory Affairs Specialist We are looking for a Regulatory Affairs Specialist to join our Health & Medical team and play a key role in ensuring our products meet regulatory and quality requirements across Australia and New Zealand. This is an exciting opportunity for a regulatory affairs professional who enjoys working in a collaborative environment, managing diverse responsibilities, and contributing to the delivery of safe, compliant, and high-quality products to market. About the Role: Reporting to the Senior Regulatory Affairs Manager Australasia, you will support the management of regulatory applications, registrations, licenses, and quality processes for Essity's Health & Medical product portfolio across Australia and New Zealand. Working closely with cross-functional stakeholders, you will help ensure compliance with regulatory requirements, quality standards, and internal governance frameworks, while supporting continuous improvement initiatives across the business. What You Will Do: Prepare and coordinate regulatory submissions to obtain and maintain approvals for products in Australia and New Zealand. Support product registrations, licenses, permits, and regulatory authorizations to ensure ongoing market supply. Maintain regulatory documentation and product-related safety information. Assist with post-market surveillance activities, adverse event reporting, and product recalls when required. Support tender submissions through the collection and management of regulatory documentation. Contribute to quality management processes, including document control, change control, CAPA activities, and quality reviews. Maintain and update relevant standards libraries and communicate changes to stakeholders. Participate in internal and external audits, including preparation, documentation review, responses, and follow-up actions. Assist with complaint handling, incident reporting, and continuous improvement initiatives. Collaborate with internal teams to prepare clear and compliant responses to audit findings and regulatory inspections. Support the ongoing enhancement of regulatory requirements and quality management systems. Who You Are: You are a detail-oriented and proactive regulatory affairs professional who thrives in a regulated environment. You enjoy working collaboratively across teams, have strong analytical skills, and are committed to maintaining high standards of quality and compliance. To be successful in this role, you will bring: At least 5 years' experience in Regulatory Affairs and/or Quality Assurance within a highly regulated industry. Experience within medical devices or a related healthcare environment will be highly regarded. Knowledge of quality management systems, ideally ISO 13485. Experience with product registrations, licensing, compliance activities, and audits. Familiarity with regulatory agency platforms such as TGA Business Services and Medsafe WAND. Strong technical writing and documentation skills. Excellent verbal and written communication skills with the ability to engage stakeholders at all levels. Strong problem-solving capabilities and a methodical approach to work. High attention to detail and the ability to manage multiple priorities effectively. Proficiency with Microsoft 365 applications. A relevant tertiary qualification is advantageous. What We Can Offer You: Our purpose, Breaking Barriers to Well-Being, provides meaning to everything we do. Join us to improve well-being for people and drive positive change for society and the environment. At Essity, you'll feel valued, empowered to grow, and challenged to achieve business results in a collaborative and open atmosphere. Innovate for Good | Excel Together | Be You With Us Application End Date: 27 Aug 2026 Job Requisition ID: Essity263876 Essity is a leading global hygiene and health company. Our expertise began with the acquisition of the Swedish company Mölnlycke in 1975, through which our roots stretch back to 1849. Today, our sustainable innovations from globally trusted brands, designed for everybody and every body, care for the well-being of 1 billion people in 150 countries every day. Working at Essity is not just a career but a chance to make the world healthier, safer, and more hygienic. We innovate for good to break barriers and contribute to shaping a healthier future. At Essity, we have a people-first approach where every career is as unique as the individual. We empower employees to excel together and reach their full potential through a winning culture driven by a powerful purpose. Our performance-orientated environment motivates employees to think differently and embrace challenges so we can continue improving lives, every day through better hygiene and health. We provide a sustainable work-life based on flexibility for both employees and employers. We are committed to Diversity, Equity, and Inclusion in everything we do. It is the key to our success in creating an inclusive, collaborative, and caring company culture where you can be you with us. Our purpose of Breaking Barriers to Well-being, enables customers and consumers to lead fuller lives at all stages of life. Our leading global brands include TENA and Tork, and other strong brands such as Actimove, Cutimed, JOBST, Knix, Leukoplast, Libero, Libresse, Lotus, Modibodi, Nosotras, Saba, Tempo, TOM Organic and Zewa are sold in 150 countries. I In 2024, Essity had net sales of approximately SEK 146bn (EUR 13bn) and employed 36,000 people. We are headquartered in Stockholm, Sweden and Essity is listed on Nasdaq Stockholm. If you want to join a company where dedication to people is powered by innovation, welcome to Essity!