This role is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with EU, UK and US regulations.
Key Responsibilities
- Preparation of updates to the Technical File
- Support FDA submissions
- Preparation of updates to the Risk Management File
- Maintaining and updating Medical Devices files and Design History Files
- Administration of Applied Standards processes
- Maintenance of Post-market Surveillance processes
- Organization of PMS meetings
- Maintenance of PMS Plans, PSUR, PMCF Plans/ Reports
- Compiling documentation and data for internal and external customers including the Notified Body
- Check, organize and update Regulatory documentation
- Support maintenance of regulatory database registrations
- Liaison with economic operators and management of documentation repositories
- A familiarity with operating to IS013485 and/or QMSR compliant processes & procedures within a medical device company
- A working knowledge of EU, UK and US regulations that affect Class II medical devices
- A Bachelor’s degree with honours or equivalent qualification in a science or engineering discipline
- 3-5 years experience of working within a regulatory department in a medical device company
Skills & Capabilities
- Excellent organizational skills and attention to detail
- Excellent analytical thinking and ability to process and organize data effectively
- A quick learner and self-motivated worker
- Good teamworking capabilities
- IT literate and capable (Excel, Word and database tools)
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