Regulatory Affairs Specialist (Orthopaedic Reconstruction) - Remote

Overview

The Regulatory Affairs Specialist will play a vital role in ensuring that Smith+Nephew's Orthopaedic Reconstruction products meet all regulatory requirements for global markets, supporting both US and international regulatory submissions.

In Short

• Prepare and support regulatory submissions for medical devices.
• Develop and implement regulatory strategies for timely product launches.
• Collaborate with project teams to ensure compliance.
• Manage databases for approved products and UDI systems.
• Stay updated with regulations and standards.
• Review engineering changes for compliance.
• Support international registrations for product portfolios.
• Use Excel for data analysis related to regulatory activities.
• Participate in internal and external audits.
• Work in a hybrid model, balancing remote and on-site responsibilities.

Requirements

• Bachelor's degree or equivalent in a scientific or technical field.
• 2-3+ years of experience in Regulatory Affairs.
• Knowledge of US & EU MDR regulatory requirements.
• Strong critical thinking and problem-solving skills.
• Ability to synthesize and implement information effectively.
• Ethical approach to regulatory compliance.
• Experience in preparing 510(k), PMA, and MDR submissions.
• Ability to develop instructions for use (IFU) content.
• Strong collaboration skills to work with cross-functional teams.
• Experience in managing regulatory databases.

Benefits

• Generous annual bonus and pension schemes.
• Flexible vacation and time off policies.
• Paid holidays and volunteering hours.
• Private health and dental plans.
• Income protection and life assurance.
• Training and mentorship opportunities.
• Discounts on gyms and fitness clubs.
• Salary sacrifice bicycle and car schemes.
• Employee discounts on various services.
• Commitment to diversity and inclusion.