Global QA/RA Specialist – Hybrid, AI-Enabled MedTech

NES Fircroft; Sydney; Hybrid; AUD 140,000 - 190,000; Full time

Benefits offered by this job

Hybrid working arrangements

Job summary

NES Fircroft is assisting an innovative Australian medical device company in Sydney to recruit a Senior Quality & Regulatory Affairs Specialist. The role focuses on maintaining cross‑border regulatory compliance and quality systems across Australia, Europe, Japan and the USA, with hands‑on involvement in audits, CAPA and product development.

You will collaborate with leadership, engineering and product teams to ensure continuous improvement of QMS, regulatory submissions and post‑market

Qualifications

• Experience in medical device regulatory affairs and quality assurance.

Responsibilities

• Support Regulatory Affairs across Australia, Europe, Japan and the United States in line with EU MDR, MDSAP, TGA, FDA and PMDA requirements.

Skills

Regulatory affairs

Quality assurance

Audits

CAPA

Risk management

QMS

Regulatory submissions

Job description

NES Fircroft is assisting an innovative Australian medical device company in Sydney to recruit a Senior Quality & Regulatory Affairs Specialist. The role focuses on maintaining cross‑border regulatory compliance and quality systems across Australia, Europe, Japan and the USA, with hands‑on involvement in audits, CAPA and product development.

You will collaborate with leadership, engineering and product teams to ensure continuous improvement of QMS, regulatory submissions and post‑market