Regulatory Affairs Specialist

Role Overview:

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

Essential Experience:

• 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

Desirable Experience:

• 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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