- Location
- Mulgrave, Australia
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Legal
- Experience
- 5+ years
- Closing date
- Today
- Source
- Workday
Description
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
