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.
About The Role
As our Post-Market Surveillance (PMS) Manager, you will be at the forefront of ensuring the ongoing safety and effectiveness of our medical devices. You will own the critical system for gathering and analysing post-market data from multiple sources, including product complaints, customer feedback, and clinical inquiries.
The role is required to make medical judgements and must be qualified to do so by having the required professional qualifications and expertise - this is due to FDA requirements.
Responsibilities
- Manage, maintain, and continuously improve the Post-Market Surveillance (PMS) system, documentation, and all related procedures.
- Advise on and implement updates to the PMS system based on new or revised regulations, guidance documents, and feedback from Notified Bodies and Competent Authorities.
- Ensure the PMS plan is executed on schedule, coordinating with cross-functional stakeholders to gather inputs and ensure global compliance (EU MDR, FDA, TGA, MEDSAP).
- Remain informed of recent and revised regulations and guidelines, assessing their impact on company PMS processes and driving necessary changes.
- Assess all incoming complaints and adverse events worldwide for medical significance, risk, and reportability.
- Manage thorough investigations into product complaints, ensuring timely and effective root cause analysis is conducted.
- Oversee the decision-making, review, preparation, and submission of MDRs and Vigilance reports to all relevant regulatory authorities.
- Prepare and review tailored clinical follow-up questionnaires for customers or sales representatives to support comprehensive complaint investigations.
- Lead the collection and analysis of PMS data, preparing for and leading periodic complaint trending meetings and PMS reviews.
- Establish and manage the process for conducting database searches of biomedical literature to identify adverse event reports and other relevant product complaints.
- Support risk-benefit evaluations by analysing data, identifying potential safety signals, and recommending Corrective and Preventive Actions (CAPAs).
- Fulfil ad-hoc requests for data analysis, data mining, and queries from cross-functional teams in support of product performance and safety deliverables.
- Partner with Regulatory Affairs, Medical Affairs, QA, and R&D; to provide expert safety input for regulatory documents, including PSURs, CERs, PMCF reports, and SSCPs.
- Serve as a key resource for internal teams, providing guidance on complaint interpretation, reportability, and regulatory submission requirements.
- Report to management on the status of project deliverables and PMS compliance activities to ensure timelines and objectives are met.
- Interface with Key Opinion Leaders (KOLs) and Medical Science Liaisons to aid in the evaluation of PMS outcomes.
- Oversee Post-Market Surveillance staff in their daily complaint management and closure activities.
- Provide direct support, training, and mentorship on PMS activities to junior staff.
- Establish and communicate clear team goals, foster an environment of inclusion and collaboration, and use performance management tools to drive team engagement and success.
About You
- A Bachelor’s degree in Bioengineering, Nursing, a related Health Science, Quality, or a Regulatory field; an advanced degree (Master's or PhD) is required
- A minimum of 8 years of experience in the medical device or pharmaceutical industry.
- At least 2 years of dedicated, hands-on experience in Post-Market Surveillance (PMS) and/or Vigilance is essential.
- Current knowledge of global medical device regulations, including EU MDR (2017/745) and FDA MDR.
- Strong understanding of quality system regulations (ISO 13485, 21 CFR 820) and risk management standards (ISO 14971).
- Direct experience with implantable medical devices is strongly desired.
- Exceptional technical writing and editing skills, with a proven ability to produce clear and accurate documentation.
- Strong ability to acquire, query, and analyse data with high attention to detail.
- Excellent interpersonal and communication skills for effective collaboration with internal teams, stakeholders, and Key Opinion Leaders (KOLs).
- Experience in training and mentoring junior staff is a significant advantage.
- Knowledge of the design, development, and clinical assessment of medical devices is highly regarded.
- Clinical experience, such as supporting clinicians in an operating room setting, is a plus.
Why PolyNovo?
Join a team that values innovation, collaboration, and professional growth. At PolyNovo, we offer a dynamic work workplace 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.
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
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📌 Post-Market Surveillance Manager
🏢 PolyNovo
📍 Melbourne