Regulatory Affairs Specialist

Role Overview

• Part of a collaborative regulatory affairs team supporting both new and existing medical devices
• Preparation of global regulatory submissions, including US 510(k) and EU technical documentation
• Work closely with project teams to develop regulatory strategies
• Maintain a working knowledge of global regulations, standards, guidance documents
• Provide support for internal and Regulatory agency audits
• Direct engagement with regulatory authorities as required
• Complete regulatory change assessments to determine impact on registrations
• Develops and maintains company Standard Operating Procedures (SOPs)
• Review product labeling to ensure compliance

Requirements

• A bachelor’s degree or equivalent experience, ideally in a scientific or technical discipline
• Working knowledge of global medical device regulations, standards and guidance
• Hands-on experience preparing or supporting regulatory submissions

Benefits

• Generous annual bonus and pension Schemes
• Save As You Earn share options.
• Flexible Vacation and Time Off
• Paid Holidays and Paid Volunteering Hours
• Private Health and Dental plans
• Healthcare Cash Plans
• Income Protection
• Life Assurance
• Discounts on Gyms and fitness clubs
• Salary Sacrifice Bicycle and Car Schemes
• many other Employee discounts