Global MedTech QA/RA Specialist (Hybrid)

Evolve Scientific; Sydney; Hybrid; AUD 130,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Global regulatory exposure

Job summary

Evolve Scientific in Sydney seeks a Senior Quality & Regulatory Affairs Specialist to lead regulatory submissions across Australia, Europe, Japan and the USA, and maintain ISO 13485 QMS compliance. You’ll work with engineering and product teams to navigate EU MDR, TGA, FDA/PMDA requirements and drive CAPA and post-market surveillance.

Ideal candidates bring hands-on, independent problem-solving in a small, collaborative MedTech environment, with strong audits experience and readiness to support

Qualifications

• Experience in Regulatory Affairs for medical devices across multiple markets.
• Demonstrated EU MDR experience (essential).
• Experience maintaining technical documentation and QMS procedures.
• Knowledge of international medical device regulations including TGA, FDA/PMDA.
• Experience supporting audits, CAPA, risk management and post-market surveillance.

Responsibilities

• Support Regulatory Affairs activities across Australia, Europe, Japan and the United States.
• Prepare, review and maintain regulatory submissions and technical files.
• Manage compliance with EU MDR, MDSAP, TGA, FDA and PMDA requirements.
• Support regulatory compliance for hardware and software medical devices.
• Collaborate with Engineering, R&D and Product Development on regulatory changes.
• Review and maintain QMS documentation, procedures and work instructions.
• Identify gaps and drive corrective and preventive actions.
• Support supplier audits and external audits.
• Contribute to CAPA, risk management and post‑market activities.
• Liaise with regulatory bodies and auditors as required.

Skills

EU MDR experience

Regulatory submissions

Quality systems

Audits & CAPA

Risk management

Independent worker

Cross-functional collaboration

Job description

Evolve Scientific in Sydney seeks a Senior Quality & Regulatory Affairs Specialist to lead regulatory submissions across Australia, Europe, Japan and the USA, and maintain ISO 13485 QMS compliance. You’ll work with engineering and product teams to navigate EU MDR, TGA, FDA/PMDA requirements and drive CAPA and post-market surveillance.

Ideal candidates bring hands-on, independent problem-solving in a small, collaborative MedTech environment, with strong audits experience and readiness to support