Health and Aged Care Professionals – Sydney NSWContract1d ago , from Health and Aged Care ProfessionalsContract prospect within a global medical device organisationWork with cutting edge technologiesExposure to a broad range of regulatory activities across the product lifecycleCollaborate with experienced global Regulatory Affairs and cross-functional teamsBenefitsContract opportunity within a global medical device organisationWork with cutting edge technologiesExposure to a broad range of regulatory activities across the product lifecycleCollaborate with experienced global Regulatory Affairs and cross-functional teamsAbout the companyJoin 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 opportunityAn 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.DutiesSupport regulatory strategies and prepare submissions and technical documentation for product approvalsConduct regulatory impact assessments for product and process changesReview QMS change orders, design change orders and non-conformance reportsAssess product changes to determine potential regulatory impact on product safety and effectivenessReview product labelling and marketing materials to ensure regulatory compliance and appropriate product claimsSupport regulatory-related CAPAs, including root cause investigations, implementation of corrective actions and effectiveness checksWork with corporate teams to support field actions and product recallsSupport post-market surveillance activitiesPartner with cross-functional teams to ensure regulatory and quality requirements are considered across projects and initiativesEnsure local Regulatory Affairs activities align with global policies and standardsSkills and ExperienceBachelor's degree in Science, Biomedical Engineering, Regulatory Affairs or a related disciplineMedical device Regulatory Affairs experience highly regardedExperience working with software-based medical device products highly desirableUnderstanding of TGA requirements, EU MDR and international medical device regulationsExperience supporting regulatory submissions and technical documentationStrong analytical skills with excellent attention to detailAbility to assess regulatory impact associated with product and process changesStrong written and verbal communication skillsConfident working across multiple stakeholders and cross-functional teamsSelf-motivated with the ability to manage competing priorities and deadlinesCultureJoin a collaborative and globally connected environment 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.
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📌 Regulatory Affairs Associatenew (New South Wales)
🏢 Health and Aged Care Professionals
📍 New South Wales