Post-Market Surveillance Data Analyst

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 Data Analyst to join the Quality team, reporting to the Director of Post-Market Surveillance. This role focuses on creating and delivering reports that highlight key data, performance indicators, trends, and opportunities for continuous improvement across PolyNovo’s products and processes.
The Data Analyst will use insights to detect process or product issues, support problem-solving initiatives, and collaborate with multiple departments to meet global medical device regulatory requirements and quality objectives.

Key Responsibilities

• Responsible for establishing or supporting general guidelines and recommended procedures for utilizing statistical techniques in the analysis of PNV products and processes. This includes, describing the guidelines for ensuring that adequate and valid statistical techniques are used for establishing, controlling and verifying the acceptability of risk management, process capability and product characteristics.
• Responsible for establishing or maintaining requirements for analyzing quality data for the purpose of continuous improvement including identifying potential quality problems. This includes describing the analysis of quality data to facilitate identification of improvement opportunities and quality problems that may require investigation and/or corrective/preventive action.
• Maintains post-market quality data integrity by limiting data access to trained and authorized users based on their roles and responsibilities, thereby preventing unauthorized modifications, deletions, or misinterpretations.
• Extracts and analyses data from the complaint management system, GxP systems, and other relevant sources to produce actionable reports. These reports support various quality-related activities, including but not limited to EU Post-Market Surveillance System, Complaint Review, Complaint Trending, Signal Detection, Management Review, CAPA investigations, Regulatory Submissions, and Regulatory Periodic Reporting.
• Supports complaint handling (intake, coding, investigations, closure) and collaborates with department stakeholders to understand their needs and translate them into actionable analytics activities.
• Develops analytical methods and implements a consistent data analytics strategy in accordance with Post-Market regulatory requirements, including monthly trend analysis and reporting, periodic post-market surveillance reviews, and post-market surveillance reporting (e.g., PMSR, PSURs, PMCF, CER).
• Extracts, analyses, and presents data from the complaint management system and other GxP systems to support global regulatory submissions, market registrations, and renewals.
• Uses software and data tools to create queries, dashboards, charts, and other outputs, helping stakeholders understand the health of post-market surveillance, quality system, and PNV product portfolio.
• Performs various activities to ensure accuracy and usability of data, including data gathering, data preparation, data transformation, and data visualization. Uses statistical tools to analyses data, make acceptance decisions, and improve process.
• Collaborates with cross-functional stakeholders to achieve regulatory and business objectives. Demonstrates the capability to lead meetings, support projects, and deliver presentations effectively.
• Utilizes business acumen, collaboration, and inquisitiveness to understand problems and identify which data can be utilized to diagnose potential causes.
• Evaluates data and identifies trends to develop solutions. Assists in various PMS and quality systems analysis, including investigations as necessary.
• Escalates identified safety and quality concerns and/or potential concerns.
• Maintains up-to-date knowledge of relevant regulations, data privacy, and security requirements to ensure compliance in data collection and reporting. Ensures adherence to all Federal, State, local, and company regulations, policies, and procedures.
• Possesses knowledge of medical device quality systems and related processes to effectively utilize the best available data for reporting requirements.
• Participates in audits and inspections, including performing data queries as requested.
• Assist PNV Quality Affairs as needed.

Qualifications: 

• Bachelor’s degree or higher in statistics (preferred), data analytics, data science, or a data related discipline.
• Experience with data and analytics in a regulated environment required. Advanced degrees or qualifications in Quality Assurance, Data Analytics, or programming tools are preferred.
  

Experience: 

• Minimum of 2-3 years of experience in a data science, data analytics, quality, and/or regulatory affairs position
• Knowledge of global Medical Device, Pharmaceutical, or Combination product regulatory requirements.
• Experience pulling data and reports to solve business problems.
• Team player while demonstrating effective negotiation and influence skills for critical compliance related topics.
• Must be organized and able to coordinate activities with internal departments and outside stakeholders.
• Good interpersonal, verbal and written communication skills. Ability to effectively negotiate and build collaboration amongst individuals.
• Experience with regulatory inspections including interacting with auditors and supporting regulatory audits is preferred.
• Experience with working in validated quality software. Working knowledge of device and/or pharmaceutical manufacturing processes desired.

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.

We like AI for lots of things… just not résumé review. Your application is read by actual human beings. No automated screening tools are used in our hiring decisions.

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/