Specialist, Regulatory Postmarket Compliance

Specialist, Regulatory Postmarket Compliance page is loaded## Specialist, Regulatory Postmarket Compliancelocations: Sydney, NSW, Australiatime type: Full timeposted on: Posted Todayjob requisition id: JR\_043963**About ResMed**At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and patient trust are at the heart of our innovation.Regulatory Affairs (RA) at ResMed is central to ensuring timely and compliant access to global markets. We work across more than 140 countries to deliver safe and effective innovations that improve quality of life. With global reach, deep technical knowledge, and strong regulatory partnerships, we lead with integrity and clarity to shape the future of health technology.**Team Overview: Regulatory Product Foundations**Regulatory Product Foundations is a team within RPSD that provides horizontal administrative, analytic, and advisory support across the four vertical Regulatory Strategy & Delivery teams. By building strong systems, processes, and tools, the team ensures that Regulatory Affairs can operate with consistency, clarity, and efficiency across the product lifecycle.The team also serves as a launchpad for talent development, offering opportunities for team members to grow into both Regulatory Affairs and Project Management pathways. In addition, Regulatory Product Foundations plays a key role in advancing the use of AI and automation, enabling greater velocity and scalability of RPSD deliverables while strengthening compliance and regulatory excellence.Within this structure, the Postmarket RA function is positioned as a vital partner in ensuring regulatory oversight and engagement once products are on the market—supporting vigilance reporting, field actions, complaints traceability, and regulatory intelligence in collaboration with global and regional stakeholders.**Position Summary**The Specialist, Regulatory Postmarket Compliance (SRPC) provides leadership and guidance on regulatory activities that safeguard ResMed's products once they are on the market. This role ensures compliance with global postmarket requirements by coordinating regulatory responses to field actions, preparing and managing submissions, and maintaining traceability across regulatory reports.Working across functions and regions, the SRPC interprets evolving standards, contributes to risk assessments, and advises stakeholders on regulatory implications of emerging data and corrective actions. The role represents Regulatory Affairs in postmarket forums, supports audit readiness, and fosters alignment between RA, Quality, Clinical, and regional teams.Through accurate reporting, proactive regulatory intelligence, and strong collaboration with internal partners and external regulators, the SRPC enables ResMed to maintain compliance, protect patient safety, and support business objectives with integrity and responsiveness.**Key Responsibilities****1. Postmarket Regulatory Leadership*** Lead and coordinate regulatory responses to postmarket events (FSCAs, recalls).* Draft, review, and reports to regulatory health authorities (FDA, TGA, EU Notified Bodies, Health Canada, and others).* Ensure accurate and timely documentation of reportable events in partnership with Quality, Clinical, and Product teams.**2. Global Compliance & Regulatory Submission*** Prepare, submit, and manage postmarket regulatory submissions and notifications.* Maintain traceability across regulatory reports.* Monitor submission progress and support follow-up actions and corrective actions.**3. Risk Analysis & Regulatory Strategy*** Contribute to cross-functional postmarket risk assessments, linking complaint data, regulatory trends, and findings.* Interpret evolving postmarket regulations and standards (e.g., EU MDR Chapter VII, ISO 13485, ISO 20416, MDSAP).* Provide strategic guidance to stakeholders on regulatory implications of corrective actions and emerging data.**4. Cross-Functional Collaboration & Audit Readiness*** Represent RA in postmarket forums and cross-functional teams.* Support audit readiness by ensuring documentation and processes meet regulatory requirements* Partner with RA, Quality, Clinical, and Regional teams to drive alignment in postmarket processes.**5. Other Duties and Requirements*** Perform additional responsibilities as required to support RA and RPSD objectives.* Contribute to process improvements and special projects across Regulatory Affairs.* Support inspections, audits, and team collaboration activities.**Qualifications & Experience****Required*** 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.**Preferred*** 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).**Who You Are**You are a compliance advocate and clear communicator who brings both regulatory insight and strategic thinking to complex challenges. You thrive in collaborative environments where patient safety, product quality, and regulatory soundness must be balanced with business needs.You bring calm clarity to urgency, structure to complexity, and are trusted to guide decisions that protect ResMed's license to operate. With a detail-oriented mindset and a global perspective, you enable ResMed to continue delivering world-class medical devices with integrity and responsiveness.Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now
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