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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 healthcare technology.
- Benefits: Competitive salary, dynamic work environment, and opportunities for professional growth.
- Other info: Join a collaborative team and work on high-impact clinical technologies.
- Why this job: Make a real impact in healthcare by ensuring safe access to advanced technologies.
- Qualifications: Degree in Life Sciences or related field; experience in regulatory affairs preferred.
The predicted salary is between 36000 - 60000 £ per year.
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.
Clinical Regulatory Specialist in Hull employer: Barrington James
Contact Detail:
Barrington James Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Regulatory Specialist in Hull
✨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 contribute to our innovative environment at StudySmarter.
✨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 your passion for regulatory affairs and how you can help us shape the future of healthcare.
We think you need these skills to ace Clinical Regulatory Specialist in Hull
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the Clinical Regulatory Specialist role. Highlight your experience with regulatory submissions and compliance activities, as these are key to what we’re looking for.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about medical technology and how your background in regulatory affairs makes you a perfect fit for our team at StudySmarter.
Showcase Your Technical Writing Skills: Since this role requires excellent technical writing, include examples of your documentation work in your application. We want to see your ability to prepare regulatory dossiers and clinical evaluation plans!
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 don’t miss any important updates from our team!
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 where you developed regulatory strategies or authored submission documents. Highlighting your hands-on experience with clinical evaluation planning and PMCF will demonstrate your capability to handle the responsibilities of the position.
✨Collaborate and Communicate
Since this role involves working with various teams, be ready to discuss how you’ve effectively collaborated with Clinical, QA/RA, and R&D teams in the past. Share instances where your communication skills helped bridge gaps between departments.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s current projects or challenges they face in regulatory affairs. This shows your genuine interest in the role and helps you gauge if the company aligns with your career goals.