You will be an important member of the Quality and Customer Support teams, liaising with key stakeholders to collect, analyze and report data effectively to allow strategic decisions. You will have the opportunity to make a significant impact within a small, motivated team with duties including:
- Supporting the Regulatory System Support Specialist in the logging and triage of customer complaints
- Gather, analyze, summarize and present customer complaints data reports in a timely manner to management to support PQE Investigations, complaints investigations in the CAPA system, post market surveillance, KPI metrics and continuous improvement initiatives
- Identify and document procedures, including statistical techniques and the extent of their use to determine, collect and analyze appropriate data aimed at showing suitability, adequacy and effectiveness of the quality management system.
- Compile and submit PSUR reports as required to support the company’s regulatory obligations under the MDR
- Making sure all customer complaints are documented and managed in a responsible, accurate and timely manner considering customer safety and regulatory/ legal requirements.
- Reviewing potential reportable events to determine if regulatory filings are required.
- Prepare summary reports in conjunction with the Regulatory Affairs Associate and the Regulatory System Support specialist.
- Technical degree preferred
- Proven experience in data analysis
- Knowledge of and experience working with systems and data analysis and statistical tools
- Knowledge of statistics and experience using statistical packages for analyzing datasets (Excel, SPSS, SAS etc)
- Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy
- Adept at queries, report writing and presenting findings
- Highly adaptable and able to work in a fast paced environment
- Excellent interpersonal and communication skills
- Ability to engage effectively at all levels of the organization
- IT proficient (Microsoft Office)