Clinical Trials, FDA, EMA Compliance
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Job Location:
Yearly Salary:
Experience Required:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Description
We are seeking a highly skilled and detail-oriented Regulatory Affairs Specialist to join a leading life sciences and medical technology 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
Required Skills:
Required Skills In-depth knowledge of GCP clinical research regulations and ethical standards Experience with clinical data collection source documentation and informed consent processes Proficiency with electronic data capture systems (e.g. REDCap Medidata or similar) Strong organizational and time management skills Excellent communication and interpersonal abilities Detail-oriented and able to handle multiple trials simultaneously Desired Skills Bachelors degree in Life Sciences Nursing or Health Sciences ACRP or SOCRA certification Previous experience in oncology cardiology or rare disease clinical trials Familiarity with clinical trial software platforms and regulatory submissions
Company Industry
IT Services and IT Consulting
Key Skills
- Abinitio
- Apprentice
- Dermatology
- Cost Estimation
- Data Networking
- Liaison
