Clinical Trials, FDA, EMA Compliance

Job Description

We are seeking a highly skilled and detail-oriented Regulatory Affairs Specialist to join a leading life sciences and medical technology organization. In this pivotal role, you will support the development, submission, and maintenance of regulatory documentation for clinical trials, product registration, and post-market surveillance activities in accordance with FDA, EMA, MHRA, and other global regulatory bodies.

This is an excellent opportunity for someone looking to contribute to regulatory strategy, gain cross-functional exposure, and work on cutting-edge biotech or medical device products within a fast-paced regulatory environment.

Job Responsibilities

• Prepare, compile, and submit regulatory documentation (INDs, CTAs, 510(k), CE marking, etc.)
  
• Ensure regulatory compliance with FDA, EMA, MHRA, ISO, and ICH guidelines
  
• Collaborate with R&D, Clinical Affairs, and Quality Assurance teams to ensure product readiness
  
• Maintain regulatory files, technical documentation, and product registrations across global markets
  
• Monitor regulatory changes and provide guidance to internal stakeholders
  
• Support internal and external audits and inspections
  
• Assist with labelling review, risk assessments, and post-market surveillance
  

Requirements

Required Skills

• Strong understanding of global regulatory requirements (FDA, EMA, MHRA, ISO 13485)
  
• Excellent written and verbal communication skills
  
• Experience preparing and submitting dossiers and regulatory filings
  
• Detail-oriented with strong documentation and project tracking skills
  
• Proficiency with Microsoft Office and regulatory software systems
  

9. Desired Skills

• Regulatory Affairs Certification (RAC) is a plus
  
• Experience in regulatory submissions for medical devices, diagnostics, or biotech products
  
• Knowledge of eCTD publishing tools and regulatory information management systems (RIMS)
  
• Ability to interpret technical documentation and scientific data
  

Benefits

Job Benefits

• Competitive salary with performance-based bonuses
  
• Private health and dental insurance
  
• Annual training and certification reimbursement
  
• 25 days holiday + bank holidays
  
• Hybrid working model and flexible scheduling
  
• Career advancement in a growing regulatory team