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