Senior Regulatory Affairs Specialist (Medtech)

TL;DR

Senior Regulatory Affairs Specialist (Medtech): Developing and executing regulatory strategies and managing product submissions for orthopedic medical devices including hardware and SaMD with an accent on TGA, EU MDR, and FDA compliance. Focus on facilitating the use of machine learning and artificial intelligence within the product portfolio and ensuring adherence to ISO 13485 and ISO 14971 standards.

Location: Brisbane, Australia (Fortitude Valley)

Company

hirify.global is an innovation-driven medical technology company dedicated to developing clinically differentiated solutions for better patient outcomes in orthopedics and beyond.

What you will do

• Develop global regulatory strategies for new product development, focusing on streamlined pathways for marketing authorization.
• Prepare and manage regulatory submissions (510k, Technical Documentation, Conformity Assessments) for the US, EU, and Australian markets.
• Collaborate with clinical affairs to execute clinical strategies and investigations required for marketing authorizations.
• Act as a regulatory SME during technical documentation audits and product development phases.
• Review labeling, marketing collateral, and QMS change orders to ensure regulatory compliance.
• Manage regulatory-related CAPAs and support field actions or recalls.

Requirements

• Bachelor’s degree in science, biomedical engineering, regulatory affairs, or a related field.
• 5+ years of experience in medical devices, healthcare, or a related industry.
• Proven expertise in US, EU, and TGA regulations, including ISO 13485 and ISO 14971.
• Must be based in Brisbane, Australia.
• Strong analytical skills and the ability to synthesize complex regulatory information.

Nice to have

• Experience with international regulatory submissions beyond the US, EU, and Australia.
• Experience working on products utilizing machine learning and/or artificial intelligence.

Culture & Benefits

• Culture of continuous improvement, global talent, and scientific excellence.
• Collaborative multidisciplinary engineering and clinical environment.
• Opportunity to work on cutting-edge enabling technologies and SaMD.
• Commitment to diversity and a harassment-free environment.