Regulatory Affairs Manager – IVDR

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

📋 Description

• Assist in the submission activities for clinical trial applications with a specific emphasis on IVDR-related processes.

• Work alongside subject matter experts to determine the relevance of IVDR and to interpret the requirements for submissions.

⛳️ Requirements

• A bachelor's degree in a pertinent scientific discipline or a healthcare-related field.

• A solid understanding of IVDR principles, encompassing its structure and fundamental concepts.

• Comprehensive knowledge of clinical trial submission processes is advantageous but not mandatory.

• Capability to conduct thorough analyses of protocols and study documents to evaluate regulatory and operational impacts.

• Excellent skills in cross-functional collaboration, stakeholder management, and coordination.

• Proficiency in handling intricate submission activities, managing competing priorities, and meeting time-sensitive deliverables.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs that may include medical, dental, and vision coverage.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.