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.
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Regulatory Affairs Specialist in Sydney employer: i-Pharm Consulting
i-Pharm Consulting is an exceptional employer that values its employees by fostering a collaborative and innovative work culture. With a focus on professional development, you will have ample opportunities to grow your expertise in regulatory affairs while working remotely across Australia and New Zealand. The company offers competitive benefits and a supportive environment that encourages meaningful contributions to the healthcare sector.
