Senior Regulatory Affairs Specialist

About the Role

Based in Frenchs Forest with hybrid working flexibility, this position is with a global medical technology organization focused on innovative solutions in orthopaedics, surgical technologies, medical devices, and digital health. The Senior Regulatory Affairs Specialist will be part of an established international Regulatory Affairs team and play a pivotal role in shaping and executing regulatory strategies across regions including Australia, the US, and Europe.

Key Responsibilities

• Design and implement regulatory strategies for both new and existing medical devices and software products.
• Lead and assist with FDA 510(k), European Union Medical Device Regulation (EU MDR), and Therapeutic Goods Administration (TGA) submissions.
• Compile, update, and maintain comprehensive regulatory and technical documentation.
• Offer regulatory advice throughout product development phases and during design modifications.
• Support regulatory frameworks specific to Software as a Medical Device (SaMD), digital health, and AI/ML-powered technologies.
• Guide teams on risk management, clinical evidence requirements, testing, and labelling standards.
• Collaborate closely with cross-functional teams including Engineering, Clinical, Quality, and Product Development departments.
• Engage with regulatory bodies such as the FDA, Notified Bodies, and TGA to support pre-submission consultations.
• Assist with post-market regulatory activities including assessments, audits, CAPAs, and product modifications.
• Stay informed on global regulatory changes and evaluate their implications for products and the business.

Candidate Requirements

• Minimum of 5 years' experience in Regulatory Affairs within medical devices or a similar regulated healthcare domain.
• Practical experience managing international regulatory submissions.
• Comprehensive understanding of FDA regulations and EU MDR requirements.
• Hands-on experience with FDA 510(k) submissions.
• Familiarity with ISO 13485 and ISO 14971 standards.
• Experience with the TGA and Australian market access processes is highly desirable.
• Exposure to SaMD, medical device software, or digital health products is a significant advantage.
• Knowledge or experience with AI and machine learning applications in medical technologies is a plus.
• Degree in Science, Biomedical Engineering, Regulatory Affairs, or related discipline.
• Excellent communication skills and confidence working across international and cross-functional teams.

Additional Information

This role offers the chance to engage beyond routine regulatory maintenance tasks by contributing to the innovation and commercialization of cutting-edge, technology-enabled medical devices. Candidates will be exposed to advanced surgical devices, navigation systems, software-driven medical tools, and emerging digital health technologies within an international setting. The position is located in Frenchs Forest, Sydney, with a hybrid working arrangement.