Medical Device Quality Regulatory jobs
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- Department of Health, Disability and AgeingSydney NSW
- Assess and manage complex medical device and IVD applications, regulatory matters and casework.
- Prepare high-quality decisions, briefs, correspondence and…
- BSIAustralia
- You’ll assess ISO13485 quality management systems and associated medical device regulatory requirements on customer sites or sometimes remotely, write up…
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- Salary Search: Medical Device Auditor IVD ISO13485(home based) salaries in Australia
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- Zimmer BiometSydney NSW
- Develop capability through hands-on exposure to the medical-device lifecycle, structured guidance and collaboration with experienced RAQA professionals.
- NicolabMelbourne VIC 3000
- At least 2 years of experience in quality assurance and/or regulatory affairs in the medical device industry.
- Experience with software as a medical device (SaMD…
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- Knowledge and skills • Strong understanding of medical device technical documentation, manufacturing processes and quality management systems.
- AbbVieSydney NSW
- Ensures regulatory inspection readiness at assigned clinical sites.
- Experience in on-site monitoring of investigational drug or device trials are required.
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- Oxoid Remel MicrobiologyGreater Adelaide SA
- Qualification in quality management or science related field (certificate, diploma or degree).
- As a QA/QC Technician you'll support the Quality Team by ensuring…
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- abmed medical technology pty ltdRemote
- Business Output: For medical device registration projects undertaken by the company in Colombia, Saudi Arabia, Mexico, and other countries, independently…
- Fresenius Medical CareSmithfield NSW 2164
- Assist in internal audits for compliance with FMC quality systems.
- Assist in internal audits for compliance with FMC quality systems.
- PSC BiotechBrisbane QLD
- Quality & Compliance Excellence – Strong understanding of cGMP, GxP principles, quality systems, validation lifecycle requirements, and global regulatory…
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- InderoRemote
- This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables within a country, region or globally.
- ParexelRemote
- Produces quality work that meets the expectations of project Team Lead and the client.
- Ensures that the project team delivers to meet the client expectations…
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- Thermo Fisher ScientificBrisbane QLD
- Serving as a resource to the operational areas on quality-related issues.
- Updating SOPs and other documents to meet current regulatory and corporate standards.
- Thermo Fisher ScientificBrisbane QLD
- Serving as a resource to the operational areas on quality-related issues.
- Updating SOPs and other documents to meet current regulatory and corporate standards.
- Anteris TechnologiesPerth WA
- The Quality Associate supports the effective operation of Quality Assurance and Quality Control activities at the Malaga site, contributing to the manufacture…
- 4DMedicalCarlton VIC 3053
- Curate and manage medical imaging datasets: de-identification, quality control, metadata management, and secure transfer/storage.
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APS Level 6 - Medical Devices Regulatory Officer - Medical Devices Authorisation Branch
Department of Health, Disability and Ageing
Sydney NSW
$101,679 - $114,709 a year
APS Level 6 - Medical Devices Regulatory Officer - Medical Devices Authorisation Branch
Department of Health, Disability and Ageing
•
Sydney NSW
•
$101,679 - $114,709 a year
Job details
$101,679 - $114,709 a year
Sydney NSW
Full job description
- APS Level 6
- $101,679 - $114,709
- Canberra, ACT, Brisbane, QLD, Melbourne, VIC, Sydney, NSW
APS6 regulatory officers contribute to the delivery of regulatory, operational and reform activities within the Medical Devices Authorisation Branch. Regulatory officers are expected to exercise initiative, sound judgement and accountability in delivering outcomes and may be assigned duties based on business and operational requirements.
Successful candidates will be placed in a merit pool and may be considered for roles across a range of functions within the Medical Devices Authorisations Branch, including regulatory assessment of medical devices (including IVD’s), regulatory operations, policy and reform, stakeholder engagement, data and business improvement activities.
Key responsiblities:
- Assess and manage complex medical device and IVD applications, regulatory matters and casework.
- Interpret and apply legislation, policies and regulatory frameworks to support sound decision-making.
- Prepare high-quality decisions, briefs, correspondence and regulatory advice.
- Deliver regulatory, operational, policy and reform activities in line with organisational priorities.
- Analyse information and data to identify risks, issues and opportunities for continuous improvement.
- Build and maintain effective relationships with internal and external stakeholders to support regulatory outcomes.
- Manage competing priorities, projects and work programs while ensuring compliance with governance requirements.
- Contribute to a positive team culture by supporting colleagues and upholding APS Values, Employment Principles and the APS Code of Conduct.
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