Health and Aged Care Professionals – Sydney NSW
Contract
1d ago , from Health and Aged Care Professionals
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
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
Solid 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 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