Risk Management and Post Market Surveillance Intern
The Post Market Surveillance Intern is responsible for:
· Analyses of Post-Market Surveillance (PMS) activities in accordance with international requirements, including US Food and Drug Administration (FDA) and European Medical Device Directive (MDD).
· Analyses of customer surveys, customer complaints, international registries, governmental databases, literature, clinical trials, in-house testing, failure analysis, and adverse event reports.
· Coordinates with Marketing, Sales, Product Development, Service, Quality, Manufacturing, and Suppliers, to ensure that needed inputs are provided as part of a comprehensive PMS program.
· Works with cross-functional areas to summarize feedback from all sources, including media, sales force, and competitive intelligence.
· Follow-up on the action assignments from PMS activities/meetings to ensure their timely completion.
· Serve as PMS point person for both new and existing products
· Coordinate risk management activities within the PMS program.
- Pursuing Bachelor’s Degree in Engineering. Pre-Med, Science, or Statistics
- Experience with Microsoft Office applications including Word, Excel, PowerPoint, Project and Outlook
- Experience with data analysis, applying statistics to data sets, statistical programs, sample size determination, and statistical software.
- Experience analyzing and determining solutions to complex problems.
- Attention to detail.
- Able to communicate effectively through multiple media types.
- Ability to deal effectively with fellow employees and external business contacts while conveying a positive, service-oriented attitude.
- Ability to work independently and as part of a team