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 counties, 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 We are seeking an experienced, strategic leader to join PolyNovo as Vice President, Quality Affairs. In this pivotal role, you will be responsible for maintaining and continually enhancing PolyNovo’s Quality Management System (QMS) in alignment with ISO 13485, FDA 21 CFR Part 820, and other applicable international standards that govern the design, development, manufacture, and distribution of medical devices. As a key member of the executive team, you will ensure ongoing ISO 13485 certification and global GMP compliance with regulatory bodies, including the Therapeutic Goods Administration (Australia), the U.S. Food and Drug Administration (FDA), our EU Notified Body, and other relevant national authorities. You will provide regular reports to senior management on the effectiveness and performance of the QMS, playing a critical role in driving a culture of quality, compliance, and continuous improvement across the organisation. You will oversee our talented Quality Assurance, Quality Control, and Post-Market Surveillance teams, leading and mentoring this high-performing group of professionals and ensuring they are supported with clear development plans and empowered to deliver excellence. Key Responsibilities Lead and manage the Quality Assurance, Post Market Surveillance and Quality Control teams. Continuously review and improve the QMS to ensure it fully reflects all processes involved in designing, developing, manufacturing and distributing PolyNovo’s medical devices. Ensure all relevant information is reflected in PolyNovo’s metrics and presented at Management Review Meetings, along with its Quality Objectives. Liaise with PolyNovo staff to develop proactive strategies to mitigate risks to device safety, performance, and efficacy (whether identified through Quality meetings or otherwise), and assign action items with timeframes for completion. Liaise with accreditation bodies to prepare for audits, host regulatory audits on behalf of management, review and update the annual audit schedule and assign trained personnel specific tasks/ accountabilities to meet QMS requirements, perform internal audits/ audits of critical suppliers in accordance with the annual schedule, and ensure all action items and Corrective Actions/ Preventative Actions are closed out within prescribed timelines. Work closely with R&D, Regulatory Affairs, Clinical Research, and Production personnel to ensure that Design History Files are created for all products, including dossiers appropriately formatted for regulatory submissions. Maintain all controlled documents in accordance with documented procedures. Ensure that Batch Process Records, QC release testing, raw material/product reports, and labelling protocols are reviewed and maintained in accordance with defined manufacturing and QMS standards. Ensure the QMS Training Matrix and documentation requirements are regularly reviewed/ updated and that departmental managers actively ensure personnel are appropriately trained to perform their function and informed of their QMS responsibilities. Ensure the VMP is reviewed annually and provide guidance to the Manufacturing and R&D departments on required validation activities, and manage the Change Control process to ensure changes are appropriately risk-assessed and that any changes in device design will not impact its safety, performance or efficacy. Provide oversight on CA/PAs and investigations into non-conforming Quality-related processes such as OOS EM, raw material and QC test results, manufacturing deviations, mislabelling devices and product transport temperature excursions. Report on the suitability, adequacy and effectiveness of the performance of the QMS to the company management as the appointed Management Representative. Responsible for medical monitoring/reporting and company post-market and vigilance activities. Manage the Post-Market Surveillance team. Provide oversight on Customer Complaints/Feedback Process; ensure the Product Complaints Register is maintained with oversight and support from Regulatory Affairs. In the event of a product recall, help coordinate the Recall Team and liaise with Regulatory Affairs personnel. Other Responsibilities Ensure collaborative relationships with PolyNovo team members and external stakeholders. Ensure all documentation is reviewed, current and compliant with the quality system and all responsibilities are carried out in accordance with the requirements of the applicable regulatory and quality processes. Ensure behaviour is in line with PolyNovo Values. PolyNovo may require you to undertake additional responsibilities or work in other areas than those outlined in this role, subject to business requirements and your skills and competencies. About You Degree in science, biomedical science/biotechnology, or related discipline (Master’s or PhD highly regarded). At least five years’ experience managing Quality Assurance functions in a regulated environment, with a deep understanding of ISO 13485 and/or GMP (21 CFR 820). Proven leadership experience, with the ability to inspire, develop, and lead high-performing quality teams. Exceptional communication and interpersonal skills, with a track record of building effective relationships with cross-functional teams, external partners, and regulatory bodies. Strong project management capabilities, including budget management, forecasting, and oversight of resources such as contractors and service providers. Excellent analytical and problem-solving skills, with the ability to manage competing priorities and oversee multiple functions simultaneously. A high level of professionalism, integrity, and a commitment to maintaining the highest standards of quality and compliance. A flexible, proactive approach to work, including a willingness to travel interstate and internationally, and to work outside standard business hours if required. A solid understanding of Australian Work Health and Safety (OHS) legislation and how it applies to quality operations. 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. J-18808-Ljbffr
