Major Tasks and Responsibilities
- Leading and manage contingent labour teams on special projects and assignments.
- Provide content input to Project teams for designing, planning and conducting analyses of safety data for the assessment of medical device safety and performance
- Provide content input to the post-marketing surveillance (PMS) program activities including, PMS system documentation, PMS planning and report management.
- Provide content input, develop and execute PMS trending methodologies, analysis, written contributions and trend report preparations
- Provides New Product Development contributions to design control for medical devices throughout the AS process
- Make recommendations based on integrated trending analyses and generate presentations in collaboration with program teams
- Support standardization of database structures and implement standard processes required for integrated trending activities
- Responsible for monitoring, analyzing and applying trending methodologies to the vigilance data submitted to Health Authorities (e.g MDRs)
- Responsible for the production and accuracy of medical device analysis and interpretation of results
- Responsible for the orchestration of PMS program activities under the ownership of PV MDS
Who you are?
- Bachelor's Degree in Mathematics or Life-science Discipline with professional experience in medical devices or similar sector
- Working understanding of medical device regulations and industry standards globally specifically 21 CFR 820, 803, ISO 13485, ISO 10993 and euMDR 2017/745
- Good scientific application of statistical methods used for evaluating complaint trends and establishing thresholds for routine trend reviews (e.g. human factor, malfunction, user interface and user safety).
- Able to develop and administer management information systems for track and trending.
- Strong analytical and technical skills that include data collection, analysis and required report generation
- Strong communication skills and ability to work both, independently and cross-functionally with Quality, Regulatory, Marketing and other applicable functions within the business
- Demonstrated ability to think outside the box and make recommendations for improvement
- Good presentation and writing skills (summary reports, evaluations, etc.)
- Fluent in English
United Kingdom : Berkshire : Reading || United Kingdom : Cambridgeshire : Cambridge