Regulatory Affairs Specialist - Medical Device (IVD)

i-Pharm Consulting; Sydney; On-site; AUD 100,000 - 140,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory Affairs

IVDR

APAC

TGA liaison

Regulatory submissions

Education

Bachelor's degree in science

Job description

Our client is a global healthcare organisation with a strong presence in diagnostics and medical devices. Its diagnostic technologies help healthcare professionals detect and manage disease, supporting better patient outcomes worldwide.

This opportunity sits within its diagnostics business, working alongside local, regional and global teams to support IVD regulatory projects across the Asia-Pacific region.

About the opportunity A global healthcare organisation is seeking a Regulatory Affairs Specialist to support IVD projects across the Asia-Pacific region, with a key focus on the transition to the In Vitro Diagnostic Medical Devices Regulation (IVDR). Reporting to the Regulatory Affairs Manager, you will work closely with regional and global teams to coordinate regulatory submissions, manage product changes and maintain registrations across designated APAC markets.

About the Role

• Support the 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, 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 agreed KPIs.
• Identify and escalation 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.

Qualifications

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

Required Skills

• Knowledge of Australian medical device and IVD regulations, relevant standards and regulatory guidance.
• Experience liaising with the TGA on pre-market and post-market matters.
• Strong project coordination skills and the ability to manage competing priorities.
• Confidence working across functions and with regional and global stakeholders.
• Excellent written and verbal communication skills, with strong attention to detail.
• A professional approach, sound judgement and a commitment to confidentiality.