APAC Reg Affairs Specialist — IVD/IVDR Focus

i‑Pharm Consulting; Sydney; Sur place; AUD 100 000 - 140 000; Plein temps

Résumé du poste

i-Pharm Consulting is assisting a global healthcare organisation in Sydney to hire a Regulatory Affairs Specialist focused on IVD projects and the IVDR transition across the APAC region.

You will coordinate regulatory submissions, manage registrations, and track project milestones while liaising with regional and global teams. The role requires strong communication, detail‑oriented oversight and compliance with applicable Australian regulations.

Qualifications

• Bachelor’s degree in science or equivalent.
• At least two years’ Regulatory Affairs experience in medical devices, ideally with IVD exposure.

Responsabilités

• Support development and delivery of regional regulatory submission plans for IVD and IVDR transition projects.
• Collaborate with global Regulatory Affairs teams, manufacturing sites, supply chain, marketing and distributors to progress submissions.
• Coordinate regulatory change control projects, gathering documentation for new registrations and amendments to existing certificates.
• Maintain regulatory databases, track milestones and report submission progress against KPIs.
• Identify and escalate risks that may affect regulatory approvals or project timelines.
• Obtain Certificates of Free Sale from the TGA to support APAC licences, including notarisation and legalisation when required.
• Provide backup support for Australian Regulatory Affairs activities, including reviewing promotional materials.
• Represent Regulatory Affairs at IVDR project and change control meetings.
• Monitor regulatory developments and communicate updates to stakeholders.
• Support broader quality and regulatory objectives as required.

Connaissances

Regulatory Affairs

IVDR

APAC

TGA liaison

Regulatory submissions

Formation

Bachelor's degree in science

Description du poste

i-Pharm Consulting is assisting a global healthcare organisation in Sydney to hire a Regulatory Affairs Specialist focused on IVD projects and the IVDR transition across the APAC region.

You will coordinate regulatory submissions, manage registrations, and track project milestones while liaising with regional and global teams. The role requires strong communication, detail‑oriented oversight and compliance with applicable Australian regulations.