- 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 qualified 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.

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 (Sydney)
🏢 Healthcare Professionals Group
📍 Sydney