Regulatory Affairs Specialist
Posted Updated
Description
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
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