Senior Quality & Regulatory Affairs Specialist - Medical Devices

About the role

An Australian medical technology company developing solutions for the orthopaedic surgical industry is looking for an experienced Senior Regulatory Affairs Specialist in Surry Hills, Sydney. The role sits with the Quality and Regulatory leadership team, supports product development and manages regulatory activities across international markets, with exposure to both medical device hardware and software. Full-time is preferred but part-time (3-4 days per week) is considered.

Key responsibilities

• Manage and support regulatory activities in line with EU MDR, TGA and FDA requirements
• Prepare, review and maintain regulatory submissions and technical documentation
• Support regulatory compliance for medical device hardware and software products
• Work with engineering and product development teams on regulatory requirements for product changes and new technologies
• Maintain compliance with international medical device standards and frameworks
• Support post-market surveillance, vigilance reporting and ongoing regulatory obligations
• Contribute to Quality Assurance activities, including QMS documentation, compliance and continuous improvement
• Liaise with internal stakeholders and external regulators, including Notified Bodies where required
• Provide practical regulatory guidance throughout the product lifecycle

Required profile

• Proven regulatory affairs experience in the medical device industry
• Hands-on EU MDR experience (essential)
• Experience supporting or managing regulatory submissions and compliance activities
• Knowledge of international medical device regulations, including TGA and ideally FDA
• Experience with medical device technical documentation
• Ability to collaborate with engineering, quality and product development teams
• Not suitable: pharmaceutical-only or IVD-only backgrounds

Required skills

• Familiarity with ISO 13485 and other medical device quality standards
• Highly regarded: orthopaedic, surgical or software-based device experience, FDA submission experience, Notified Body responses, and exposure to both regulatory affairs and quality assurance

What we offer

• Salary of $130,000-$150,000 plus superannuation, depending on experience
• Permanent position with part-time flexibility
• Hybrid working, up to two days from home after initial onboarding
• Exposure to international regulatory requirements and product development