Regulatory Affairs Associate (Graduate Level) - Remote

Overview

The Regulatory Affairs Associate at Smith+Nephew plays a crucial role in ensuring that medical devices meet regulatory requirements for global markets, contributing to high impact projects and optimizing processes in a collaborative team environment.

In Short

• Ensure compliance of products with regulatory requirements.
• Support development and implementation of regulatory strategies.
• Author and compile product submissions and technical files.
• Provide regulatory inputs for cross-functional projects.
• Assess regulatory impact of changes to existing devices.
• Support regional registration and renewal requests.
• Author labeling literature and review advertising materials.
• Support technical file and quality audits.
• Collaborate with a diverse team to innovate processes.
• Engage with various stakeholders in the medical device industry.

Requirements

• Bachelor's degree or equivalent experience in a scientific or technical field.
• Passion for learning and curiosity about regulatory affairs.
• Confident and driven to do the right thing.
• Ability to engage and work well with diverse teams.
• Strong communication and documentation skills.
• Understanding of medical device regulations.
• Experience in regulatory submissions is a plus.
• Ability to assess changes for regulatory impact.
• Detail-oriented with strong analytical skills.
• Commitment to diversity and inclusion in the workplace.

Benefits

• Pension Schemes and Save As You Earn share options.
• Flexible Holidays and Time Off.
• Paid Holidays and Paid Volunteering Hours.
• Healthcare Cash Plans and Life Assurance.
• Hands-On, Team-Customised Training and Mentorship.
• Discounts on Gyms and fitness clubs.
• Salary Sacrifice Bicycle and Car Schemes.
• Employee discounts on various services.
• Supportive and inclusive work environment.
• Opportunities for career advancement.