Regulatory Affairs Specialist

i-Pharm Consulting; Sydney; Híbrido; AUD 90.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory affairs

Communication skills

Project coordination

Cross-functional collaboration

Educación

Bachelor’s degree in science

Descripción del empleo

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.

Key responsibilities

• 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 escal​e 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.

About you

• 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.
• 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.

Contract and working arrangements

• Duration: One-year contract.
• Working pattern: Five days per week, with four days onsite and one day working from home.
• Project focus: IVD regulatory projects, including IVDR transition activities across APAC.