Postmarket Regulatory Specialist
17 hours ago
Regulatory Specialist for Postmarket Compliance
">Job DescriptionIn this key role, you will provide leadership and guidance on regulatory activities that safeguard ResMed products once they are on the market.
This involves ensuring compliance with global postmarket requirements by coordinating regulatory responses to field actions, preparing and managing submissions, and maintaining traceability across regulatory reports.
As a Regulatory Specialist, you will interpret evolving standards, contribute to risk assessments, and advise stakeholders on regulatory implications of emerging data and corrective actions.
You will represent Regulatory Affairs in postmarket forums, support audit readiness, and foster alignment between RA, Quality, Clinical, and regional teams.
Through accurate reporting, proactive regulatory intelligence, and strong collaboration with internal partners and external regulators, you will enable ResMed to maintain compliance, protect patient safety, and support business objectives with integrity and responsiveness.
">Required Skills & Qualifications- Bachelor's degree in biomedical engineering, life sciences, or a related field.
- Minimum 6 years of experience in Regulatory Affairs or Quality Assurance in a regulated medical device environment.
- Demonstrated expertise in postmarket regulatory functions, including vigilance reporting, complaint handling, and FSCAs.
- Strong technical writing and documentation skills, with attention to regulatory accuracy and detail.
- Proven ability to work cross-functionally on risk, complaints, or field actions.
- Experience with international submissions (e.g., Medical Device Reports, FSCAs, PSURs).
- Knowledge of ISO 13485, ISO 14971, ISO 20416, and regional reporting requirements under EU MDR, FDA, and MDSAP frameworks.
- Experience supporting external audits or inspections by health authorities or notified bodies.
- Familiarity with regulatory and management systems (e.g., Jira, RIMSYS).
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Postmarket Regulatory Specialist
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Specialist, Regulatory Postmarket Compliance
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Sydney, New South Wales, Australia beBeeCompliance Full time $180,000 - $220,000Job DescriptionWe are seeking a highly skilled professional to fill the role of Regulatory Compliance Specialist - Postmarket in our organization.This position is responsible for ensuring compliance with global postmarket requirements by coordinating regulatory responses to field actions, preparing and managing submissions, and maintaining traceability...
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