Who we are PolyNovo is a disruptive medical technology company, headquartered in Melbourne. We design, develop, and manufacture innovative dermal regeneration solutions, using our patented bioabsorbable polymer technology NovoSorb®. Our lifesaving products have revolutionised the treatment of burns, major trauma as well as multiple emerging indications, and impacted the lives of over 70,000 patients globally. With a footprint in 46 countries and 300 staff across a range of locations, PolyNovo continues to grow, and opportunity awaits. Learn more about PolyNovo by visiting our Website or our LinkedIn page. About The Role PolyNovo is seeking a Post-Market Surveillance Senior Associate to join the Quality team, reporting to the Director of Post-Market Surveillance. This role is responsible for establishing and maintaining monitoring systems to ensure the safety and effectiveness of PNV’s devices post-market. The role will also be involved in preparing Post-Market Surveillance Reviews, Plans, and Periodic Safety Update Reports (PSUR), validating analysed data and trend reports, and supporting or leading continuous improvement projects. Key Responsibilities Administer the PMS Systems to ensure continued compliance, identifying potential gaps; Recommend changes to the PMS System in response to updated or newly released guidance documents, feedback from Notified Bodies and Competent Authorities, regulatory changes, and other relevant industry publications. Maintain PMS procedures and documentation in compliance with worldwide regulatory requirements to support product lines. Assess the regulatory reportability of all complaints and adverse events for their medical significance and relevance to product risk management and escalate serious complaints or adverse events. Prepare and review tailored clinical follow-up questionnaires related to reported product events for external customers or sales representatives, with the objective of supporting reportability assessments and ensuring comprehensive complaint investigations. Provide information to PMS members and the QA and R&D teams regarding complaint interpretation, reportability, event investigation, coding, regulatory submission requirements (such as MDRs/Vigilances), and complaint resolution. Responsible for searching biomedical literature databases to identify and review adverse events and product complaints for PolyNovo’s marketed products. Interprets high-level trends – reviews and validates the analyzed data to identify significant safety signals or performance issues. Evaluates the risk-benefit ratio of the device and assesses the need for further investigation. Prepare or lead periodic complaint trending meetings, PMS review, Complaint training or as assigned. Support cross functional teams and stakeholder groups on ad-hoc data analysis, data mining, data queries in support of product performance, regulatory, compliance and other product and safety focused deliverables/ requirements. Manage PMS activities according to schedule, gather inputs from cross-functional stakeholders, and escalate at-risk findings to senior management. Handle investigations into product complaints, ensuring timely and thorough root cause analysis. Guide decision-making and handle the review of medical device reports (MDR) and vigilance submissions to regulatory authorities across all jurisdictions; prepare and submit PMS regulatory reports and Vigilance reports. Track and coordinate the execution of PMS plan according to global requirements, ensuring global compliance to all PMS activities, such as alignment with the FDA, EU MDR, TGA, MEDSAP requirements. Report to management on the status of project deliverables; and PMS compliance activities to ensure timelines are met. Collaborate with Medical Affairs, QA, PMS, and Regulatory Affairs to provide safety input and analysis for regulatory documents—including BRA, SSCP, CERs, PMCF, PSUR, and PMSR—ensuring compliance and accurate benefit/risk assessments. Remain informed of new or revised regulations and/or guidelines and assesses impact on company post market surveillance processes. Handle Post-Market Surveillance activities by assisting with complaint management and contributing to the resolution and closure of cases as needed. Escalate possible safety signals/issues to the department leaders. Interface with Key Opinion Leaders (KOL) and Medical Science Liaisons for the evaluation of PMS outcome. Qualifications: Qualifications in Quality, Regulatory, Medical, Clinical Nursing Practitioner, Bioengineering, Risk Management or other Health Sciences professional qualifications – preferably at Masters or PhD level; Experience: 8 years’ experience in medical device or drug industries - preferably in implantable medical devices - including at least two years’ experience in post-market surveillance/ vigilance - essential; Current knowledge of Medical Device Regulation (EU) 2017/745 and FDA MDR and the medical device industry; Knowledge of the design, development and clinical assessment of medical devices highly regarded; Understanding of quality system regulations (ISO13485; 21CFR820) for medical devices as well as risk management and ISO14971 (ISO standard for the application of risk management to medical devices) Why PolyNovo? Join a team that values innovation, collaboration, and professional growth. At PolyNovo, we offer a dynamic work environment and the opportunity to contribute to ground-breaking projects that shape the future of our company and the industry. Multinational, ASX 200 listed and values-led business dedicated to redefining healing for the benefit of our patients Unique platform technology, an exciting pipeline of highly innovative products Diverse, inclusive and flexible workplace culture Career development opportunities and unlimited access to online learning Rewards platform with access to discounts at over 450 Australian retailers Paid parental leave for primary and secondary carers, Nurture Days, and more Salary packaging including novated car leasing. Apply Today Please send your resume by clicking on the Apply button. Please note that, due to the high level of interest expected, only shortlisted candidates will be contacted. Please note only applicants with full working rights in Australia will be considered. PolyNovo is committed to creating a workplace that values equity, diversity, and inclusion. We recognise and value that it is the sum of our parts – our combined backgrounds, experiences and perspectives – that allow us to succeed. Learn more about PolyNovo at: https://au.polynovo.com/company/
