Clinical Trials, FDA, EMA Compliance

London, United Kingdom Posted on 03/11/2025

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City London
• Province City of London
• Country United Kingdom
• Postal Code EC1M

About Us

MastarRec is a specialist recruitment and staffing agency supporting high-growth and technology-driven industries across the United Kingdom, the United States, and global markets. We partner with organizations to deliver tailored staffing solutions focused on quality, integrity, and long-term value for both clients and candidates.

Job Description

Job Description

We are seeking a highly skilled and detail-oriented RegulatoryAffairs Specialist to join a leading life sciences and medical technologyorganization. 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 inaccordance with FDA, EMA, MHRA, and other globalregulatory bodies.

This is an excellent opportunity for someone looking tocontribute to regulatory strategy, gain cross-functional exposure, and work oncutting-edge biotech or medical device products within afast-paced regulatory environment.

Job Responsibilities

• Prepare,compile, and submit regulatory documentation (INDs, CTAs, 510(k), CEmarking, etc.)
  
• Ensureregulatory compliance with FDA, EMA, MHRA, ISO, and ICH guidelines
  
• Collaboratewith R&D, Clinical Affairs, and Quality Assurance teams to ensureproduct readiness
  
• Maintainregulatory files, technical documentation, and product registrationsacross global markets
  
• Monitorregulatory changes and provide guidance to internal stakeholders
  
• Supportinternal and external audits and inspections
  
• Assistwith labelling review, risk assessments, and post-market surveillance
  

Requirements

Required Skills

• Strongunderstanding of global regulatory requirements (FDA, EMA, MHRA, ISO13485)
  
• Experiencepreparing and submitting dossiers and regulatory filings
  
• Detail-orientedwith strong documentation and project tracking skills
  
• Proficiencywith Microsoft Office and regulatory software systems
  

9. Desired Skills

• RegulatoryAffairs Certification (RAC) is a plus
  
• Experiencein regulatory submissions for medical devices, diagnostics, or biotechproducts
  
• Knowledgeof eCTD publishing tools and regulatory information management systems(RIMS)
  
• Abilityto interpret technical documentation and scientific data
  
• Competitivesalary with performance-based bonuses
  
• Privatehealth and dental insurance
  
• Annualtraining and certification reimbursement
  
• 25days holiday + bank holidays
  
• Hybridworking model and flexible scheduling
  
• Careeradvancement in a growing regulatory team