APAC IVDR Regulatory Specialist

i‑Pharm Consulting; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Job summary

i‑Pharm Consulting is seeking a Regulatory Affairs Specialist to support IVD projects across the Asia-Pacific region, with a focus on IVDR transition. Reporting to the Regulatory Affairs Manager, you will coordinate regulatory submissions, manage changes, and maintain registrations with regional teams.

The role requires a Bachelor’s degree in science, at least two years in medical devices regulatory affairs, and strong collaboration across functions.

Qualifications

• Bachelor’s degree in science or equivalent.
• At least two years’ Regulatory Affairs experience in medical devices, ideally with IVD exposure.
• Knowledge of Australian medical device and IVD regulations, standards and guidance.
• Experience liaising with the TGA on pre‑ and post‑market matters.
• Strong project coordination skills and the ability to manage competing priorities.
• Excellent written and verbal communication with strong attention to detail.

Responsibilities

• Coordinate regional regulatory submissions for IVD and IVDR projects.
• Collaborate with global/regional teams, manufacturing sites, supply chain, marketing, commercial teams and distributors to progress submissions.
• Coordinate regulatory change control projects, gathering documentation to support new registrations and amendments to existing product certificates.
• Maintain regulatory databases, track project 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 licence renewals, including coordinating notarisation and legalisation where required.
• Provide backup support for Australian Regulatory Affairs activities, including reviewing promotional materials against applicable requirements.
• Represent Regulatory Affairs at IVDR project and change control meetings.
• Monitor regulatory developments, assess their impact and communicate relevant updates to stakeholders.
• Support broader quality and regulatory objectives as required.

Skills

Regulatory affairs

Communication skills

Project coordination

Cross-functional collaboration

Education

Bachelor’s degree in science

Job description

i‑Pharm Consulting is seeking a Regulatory Affairs Specialist to support IVD projects across the Asia-Pacific region, with a focus on IVDR transition. Reporting to the Regulatory Affairs Manager, you will coordinate regulatory submissions, manage changes, and maintain registrations with regional teams.

The role requires a Bachelor’s degree in science, at least two years in medical devices regulatory affairs, and strong collaboration across functions.