Benefits Contract opportunity within a global medical device organisation Work with cutting edge technologies Exposure to a broad range of regulatory activities across the product lifecycle Collaborate with experienced global Regulatory Affairs and cross-functional teams About the company Join a global medical technology organisation focused on developing innovative products that support improved patient outcomes. Operating across highly regulated international markets, the business has a strong focus on quality, compliance and continuous improvement, with established teams across Regulatory Affairs, Quality, Engineering and other key functions. About the opportunity An exciting contract opportunity is available for a Regulatory Affairs professional to join a global medical device organisation. Working as part of a global Regulatory Affairs function, you will support a broad range of regulatory activities across the product lifecycle. This is a varied role covering regulatory submissions, technical documentation, product and process change assessments, post-market activities, CAPA, labelling and regulatory compliance. You will work closely with cross-functional teams and provide regulatory guidance to ensure products continue to meet applicable regulatory requirements. Duties • Support regulatory strategies and prepare submissions and technical documentation for product approvals • Conduct regulatory impact assessments for product and process changes • Review QMS change orders,



design change orders and non-conformance reports • Assess product changes to determine potential regulatory impact on product safety and effectiveness • Review product labelling and marketing materials to ensure regulatory compliance and appropriate product claims • Support regulatory-related CAPAs, including root cause investigations, implementation of corrective actions and effectiveness checks • Work with corporate teams to support field actions and product recalls • Support post-market surveillance activities • Partner with cross-functional teams to ensure regulatory and quality requirements are considered across projects and initiatives • Ensure local Regulatory Affairs activities align with global policies and standards Skills and Experience • Bachelor’s degree in Science, Biomedical Engineering, Regulatory Affairs or a related discipline • Medical device Regulatory Affairs experience highly regarded • Experience working with software-based medical device products highly desirable • Understanding of TGA requirements,



EU MDR and international medical device regulations • Experience supporting regulatory submissions and technical documentation • Strong analytical skills with excellent attention to detail • Ability to assess regulatory impact associated with product and process changes • Strong written and verbal communication skills • Confident working across multiple stakeholders and cross-functional teams • Self-motivated with the ability to manage competing priorities and deadlines Culture Join a team-oriented and globally connected workplace where Regulatory Affairs works closely with Quality, Engineering and broader business teams. The organisation values initiative, sound judgement, professionalism and continuous improvement, with a strong focus on delivering safe and compliant medical devices. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on [email protected] for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. • Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific; • Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs; • Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D;, Legal, Manufacturing, Operations, Supply Chain, Warehouse; • Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.

📌 Regulatory affairs associate (Australia)
🏢 Healthcare Professionals Group
📍 Australia