Hybrid Post-Market Surveillance Data Analyst

at PolyNovo Limited

• Job title: Post-Market Surveillance Data Analyst
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Port Melbourne, Australia

About the role

• Data Analyst focusing on Post-Market Surveillance at PolyNovo, an innovative medical tech company. Delivering reports that highlight key data, trends, and opportunities for continuous improvement.

Responsibilities

• Responsible for establishing or supporting general guidelines and recommended procedures for utilizing statistical techniques in the analysis of PNV products and processes
• Responsible for establishing or maintaining requirements for analyzing quality data for the purpose of continuous improvement including identifying potential quality problems
• Maintains post-market quality data integrity by limiting data access to trained and authorized users based on their roles and responsibilities
• Extracts and analyses data from the complaint management system, GxP systems, and other relevant sources to produce actionable reports
• 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
• 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
• 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

Requirements

• 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
• 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

Benefits

• Rewards platform with access to discounts at over 450+ Australian retailers
• Paid parental leave for primary and secondary carers
• Nurture Days
• Salary packaging including novated car leasing