Senior Regulatory Affairs Specialist (Medical Devices)

Location: Brisbane, Queensland, Australia; primarily office-based with occasional travel to manufacturing sites, clinical validation sites, and surgeon workshops.

Company

hirify.global is a medical technology company developing clinically differentiated orthopedic products, services, and integrated technologies to improve patient outcomes and transform healthcare workflows.

What you will do

• Develop global regulatory strategies and streamlined marketing authorization pathways for new and modified orthopedic medical devices.
• Prepare and manage regulatory submissions and technical documentation for the US, EU, and Australian markets, including responses to reviewer questions and deficiencies.
• Lead or support pre-submission meetings with the FDA, Notified Bodies, and the TGA, and coordinate clinical strategies with Clinical Affairs.
• Represent Regulatory Affairs on product development teams, advising on predicates, verification and validation, risk management, standards, and regulatory compliance.
• Assess product and process changes, manage notifications and amendments, and review quality and design change orders for regulatory impact.
• Support post-market surveillance, audits, CAPAs, field actions, recalls, labeling reviews, and ongoing regulatory compliance activities.

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.
• Experience preparing US, European, and Australian regulatory submissions, including 510(k), technical documentation, and conformity assessments.
• Expertise in US, EU, and TGA regulations, ISO 13485, ISO 14971, and the MTAA Code of Practice.
• Strong analytical, problem-solving, written and oral communication, quality management, prioritization, and stakeholder collaboration skills.
• Ability to work independently, influence cross-functional teams, and manage complex regulatory activities with attention to detail.

Nice to have

• Experience with international regulatory submissions.
• Experience working on products incorporating machine learning or artificial intelligence.

Culture & Benefits

• Collaborative work across engineering, clinical, quality, sales, operations, and corporate functions.
• Occasional travel to manufacturing and clinical sites and surgeon workshops.
• Hands-on interaction with surgical instruments, navigation hardware, and integrated testing environments.
• Focus on scientific excellence, continuous improvement, product safety, reliability, and better patient outcomes.
• Equal employment opportunity and reasonable accommodation practices.