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- Tasks: Support regulatory documentation for clinical trials and product registrations in a fast-paced environment.
- Company: Leading life sciences and medical technology organisation with a focus on innovation.
- Benefits: Competitive salary, private health insurance, flexible working, and career advancement opportunities.
- Why this job: Make a real impact in biotech and medical devices while gaining valuable regulatory experience.
- Qualifications: Strong understanding of global regulations and excellent communication skills required.
- Other info: Join a dynamic team with opportunities for training and professional growth.
The predicted salary is between 36000 - 60000 £ per year.
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
- 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
- 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
Additional Requirements
- 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
- Bachelor’s 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
Clinical Trials, FDA, EMA Compliance in London employer: MastarRec
Contact Detail:
MastarRec Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Trials, FDA, EMA Compliance in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be when it comes to landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA, EMA, and MHRA regulations. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your career goals. Use our website to find roles that excite you and match your skills in regulatory affairs. We’ve got plenty of opportunities waiting for you!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. We believe this small gesture can help keep you top of mind for hiring managers.
We think you need these skills to ace Clinical Trials, FDA, EMA Compliance in London
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Affairs Specialist role. Highlight your experience with FDA, EMA, and other regulatory bodies, as well as any relevant projects you've worked on. We want to see how your skills align with our needs!
Showcase Your Attention to Detail: In this role, being detail-oriented is key! Use your application to demonstrate your meticulous nature. Include examples of how you've successfully managed documentation or compliance in previous roles. This will help us see that you’re the right fit for our fast-paced environment.
Communicate Clearly: Your written communication skills are crucial for this position. Ensure your application is clear, concise, and free of jargon. We appreciate straightforward language that gets to the point, so let your personality shine through while keeping it professional!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about our company culture and values!
How to prepare for a job interview at MastarRec
✨Know Your Regulations
Make sure you brush up on the specific regulatory requirements for FDA, EMA, and MHRA. Being able to discuss these in detail will show your understanding of the role and impress the interviewers.
✨Showcase Your Documentation Skills
Prepare examples of your previous work with regulatory documentation. Bring along samples or be ready to discuss how you’ve successfully compiled and submitted dossiers in the past.
✨Collaborate Like a Pro
Highlight your experience working with cross-functional teams. Be prepared to share specific instances where you collaborated with R&D, Clinical Affairs, or Quality Assurance to ensure product readiness.
✨Stay Updated on Regulatory Changes
Demonstrate your proactive approach by discussing how you keep abreast of changes in regulations. Mention any tools or resources you use to monitor updates, as this shows your commitment to compliance.