Regulatory Affairs AssociateNew in Sydney

Contract opportunity within a global medical device organisation.

Work with cutting edge technologies and 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 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.