Regulatory Affairs Specialist
$45,000–$65,000 year
HybridLondon, England, United Kingdom
Job Summary
Prepare, compile, and submit regulatory documentation including INDs, CTAs, 510(k), and CE marking in accordance with FDA, EMA, MHRA, and ISO guidelines. Collaborate with R&D, Clinical Affairs, and Quality Assurance teams to ensure product readiness while maintaining regulatory files and technical documentation across global markets. Monitor regulatory changes to provide guidance to internal stakeholders and support internal and external audits and inspections. Assist with labelling review, risk assessments, and post-market surveillance activities. This role offers competitive salary with performance-based bonuses, private health and dental insurance, and annual training reimbursement within a hybrid working model.
Required Qualifications
- 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
Desired Qualifications
- 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
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