Australia Job Openings
ResMed
Specialist, Regulatory Postmarket Compliance
FULL TIME
October 28, 2024
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Plan and coordinate regulatory post market strategies.
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Represent Regulatory Affairs on selected post market cross-functional teams (XFT's).
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Develop and implement submissions to regulatory authorities such as FDA, TGA and Notified Body for post market projects.
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Analyse the scientific content of submissions to ensure they are accurate and soundly presented.
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Monitor the status of submissions and advise stakeholders of their progress.
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Monitor external standards: e.g., post market standards (ISO, IEC, etc.), European harmonized standards, FDA policies and guidance, national and international regulatory requirements, industry journals, etc.
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Monitor internal standards and act appropriately.
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Maintain an up-to-date knowledge on all regulatory matters and advise senior management of potentially significant changes to post market strategies.
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Manage the continuance of regulatory compliance (post market) of existing Res Med products in selected region(s).
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Ensure clinical trials are conducted in accordance with the best opportunity to achieve regulatory approval.
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Provide post market regulatory support (e.g., Medical Device Reporting) and guidance as required.
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Manage special projects as required.
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Engineering or Science Degree
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Six (6) related experience with a medical manufacturer or equivalent combination of education and experience
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Knowledge of EU MDR regulations
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Must be detail oriented & highly organized.
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Ability to work independently and exercise judgment with limited supervision.
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Must possess strong interpersonal communication skills.
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Ability to prioritize workload with limited supervision.
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Must demonstrate teamwork building skills in & outside department.
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Ability to exercise judgment.
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