Senior Regulatory Affairs Officer - Cumbernauld, United Kingdom - GC Aesthetics

Description

This role within the Regulatory team is to support the Regulatory Manager in ensuring compliance with regulations within Europe and globally, to register new and existing products with regulatory authorities to allow for growth of the business and to manage key regulatory projects within the business.

• Maintenance of Design Dossiers for Class IIa, IIb and III products.
• Preparation of regulatory submissions for global product registrations
• Leading key regulatory projects across the business
• Development of regulatory strategies aligning with market and business objectives.
• Provide input to content and compliance of IFUs, packaging and labelling materials and marketing literature
• Will deputise for the RA manager in their absence.

• Maintain and communicate clear registration plans with timelines for all assigned registrations to grow the business
• Maintain Technical files in compliance with current and changing regulations
• Lead assigned key regulatory projects and communicate to stakeholders the progress of the project
• Lead new product development and change projects and communicate to stakeholders the progress of the project

• Relevant science or engineering degree.
• Proven experience of working in a similar regulatory role
• Knowledge of regulatory standards and global regulations for medical devices.
• Excellent facilitation, coordination, prioritization, and communication skills.
• Proven ability to manage and prioritise workload, meet deadlines, and work in a pressurized environment.
• Must be able to work crossfunctionally and be able to lead business projects and change projects for products and processes.