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- Tasks: Shape regulatory strategies for cutting-edge surgical AI and digital health solutions.
- Company: Innovative medical tech company at the forefront of surgical AI.
- Benefits: Competitive salary, career growth, and the chance to impact healthcare.
- Why this job: Join a dynamic team and help bring advanced healthcare solutions to patients.
- Qualifications: Degree in Life Sciences or related field; regulatory experience preferred.
- Other info: Collaborative environment with opportunities to work on high-impact projects.
The predicted salary is between 36000 - 60000 £ per year.
About the Role
I am seeking a Clinical Regulatory Specialist to join an innovative medical technology company at the forefront of surgical AI and digital health. The role is critical to ensuring clinical evidence, regulatory submissions, and compliance activities meet UK and international medical device regulations. You will work across clinical, regulatory, and R&D teams to enable safe and timely access to cutting-edge healthcare solutions.
Key Responsibilities
- Develop and execute regulatory strategies for clinical evidence and submissions in the UK (MHRA/UKCA) and support international regulatory planning.
- Prepare and author regulatory dossiers, clinical evaluation plans, and submission documents.
- Interpret and advise on UK and international medical device regulations, including UKCA, UK MDR, EU MDR, ISO 14155, ICH-GCP, and SaMD guidance.
- Collaborate with Clinical, QA/RA, and R&D teams to define clinical evidence requirements.
- Evaluate clinical literature, trial data, post-market data, and real-world evidence to support regulatory submissions.
- Maintain and update regulatory files, design dossiers, technical documentation, and clinical evaluation reports.
- Support post-market clinical follow-up (PMCF) planning and execution.
- Provide regulatory guidance and training to internal teams on clinical regulatory requirements.
- Serve as a regulatory point of contact with regulatory authorities as required.
Qualifications:
- Degree in Life Sciences, Biomedical Engineering, Medicine, Pharmacy, or related field.
- Regulatory qualifications (e.g., RAC, MSc in Regulatory Affairs) are advantageous.
Experience:
- 3–7+ years in regulatory affairs or clinical regulatory roles within medical devices, SaMD, digital health, or similar sectors.
- Experience with clinical evaluation planning, clinical literature review, PMCF, and regulatory submissions.
- Exposure to MHRA/UKCA processes and EU MDR/CE marking is desirable.
Technical Knowledge:
- Strong understanding of UK and international regulatory frameworks for medical devices and SaMD.
- Knowledge of clinical regulations including UKCA, ISO 14155, ICH-GCP, and post-market surveillance.
- Ability to interpret complex clinical and regulatory guidance for strategic application.
Skills:
- Excellent technical writing and documentation skills.
- Strong analytical skills and attention to detail.
- Collaborative team player with effective communication across multidisciplinary teams.
Why Apply?
This is a unique opportunity to join an innovative medical technology company operating at the intersection of AI, surgery, and digital health. You will play a key role in shaping regulatory strategy for high-impact clinical technologies, helping bring advanced surgical solutions safely to patients.
Interested in this position? Apply now!
Clinical Regulatory Specialist in London employer: Barrington James
Contact Detail:
Barrington James Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Regulatory Specialist in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical technology field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Clinical Regulatory Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UKCA and EU MDR regulations. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise!
✨Tip Number 3
Showcase your collaborative skills! During interviews, share examples of how you've worked with cross-functional teams. We want to see how you can bring that team spirit to our innovative projects.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re excited to see how you can contribute to our mission in surgical AI and digital health.
We think you need these skills to ace Clinical Regulatory Specialist in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in regulatory affairs and clinical roles. We want to see how your background aligns with the responsibilities mentioned in the job description, so don’t hold back on showcasing relevant projects!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about the role and how your skills can contribute to our innovative team. Keep it concise but impactful – we love a good story!
Showcase Your Technical Writing Skills: Since excellent technical writing is key for this role, consider including examples of your documentation or regulatory submissions. This will give us a taste of your writing style and attention to detail, which are super important for a Clinical Regulatory Specialist.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s easy peasy!
How to prepare for a job interview at Barrington James
✨Know Your Regulations
Make sure you brush up on UK and international medical device regulations like UKCA, UK MDR, and EU MDR. Being able to discuss these confidently will show that you’re not just familiar with the role but also passionate about compliance and safety in healthcare.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in regulatory affairs, especially in clinical evaluation planning and submissions. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Collaborative Mindset
Since this role involves working with various teams, be ready to discuss how you’ve successfully collaborated with clinical, QA/RA, and R&D teams in the past. Share anecdotes that demonstrate your teamwork skills and how you’ve navigated challenges together.
✨Technical Writing Skills
As a Clinical Regulatory Specialist, strong technical writing is key. Bring along samples of your previous work, like regulatory dossiers or clinical evaluation plans, to showcase your documentation skills. This will give the interviewers a tangible sense of your capabilities.
