Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee and assist with Regulatory initiatives.

• Prepare medical device submissions for the US and UK/EU markets.

• Manage renewals and product applications with local Authorities.

• Assist with MDR submissions in the EU.

• Perform Regulatory impact evaluations.

⛳️ Requirements

• Master’s degree in pharmaceutical sciences, chemistry, biology, or a related field.

• A minimum of 4 years of experience in Regulatory affairs, preferably within the medical device sector.

• Methodical and organized approach to tasks.

• Previous experience with FDA 510(k) and EU MDR 2017/745 regulations.

• Strong project management capabilities and problem-solving abilities.

• Proficient in Microsoft Office Suite.

• Attention to detail is essential.

• Fluency in English (both spoken and written) is required.

• A proactive attitude, positive outlook, and empathy are important.

• Ability to work collaboratively in a team environment.

🏝️ Benefits

• Opportunities for professional development and growth.

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness programs.

• Flexible working arrangements.