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For Companies At a Glance
- Tasks: Join our team to ensure quality and regulatory compliance for innovative medical devices.
- Company: King's College London, a leader in healthcare engineering and innovation.
- Benefits: Full-time role with a competitive salary and opportunities for professional growth.
- Why this job: Make a real difference in healthcare by working on cutting-edge medical technologies.
- Qualifications: Experience in medical device regulations and quality management systems required.
- Other info: Collaborative environment with exciting projects in MedTech and digital health.
The predicted salary is between 36000 - 60000 £ per year.
About Us
We are seeking experts in medical device design regulatory processes to join our team and work with project groups to translate novel technologies to the clinic.
We welcome applications from individuals with experience in:
- Software as a Medical Device
- Design Controls
- IEC 60601
- Regulatory Affairs supporting MedTech start-up organisations
- Quality Management Implementation
The post holders will be based in the London Institute for Healthcare Engineering (LIHE), part of the School of Biomedical Engineering and Imaging Sciences, King's College London.
About The Role
Located within a hospital environment, our mission is to generate tangible clinical and commercial translation through our stimulating collaborations to achieve the unexpected, and advance research, innovation and teaching progress through our shared mission of engineering better health for patients worldwide.
The post holders will support a wide variety of research projects in the School and start-up companies as part of our MedTech Venture Builder and Accelerator programmes in the MedTech and Digital Health Hubs to develop new class I to class III medical devices and healthcare technology.
They will operate within the Medical Engineering Quality Management System (QMS), developed to meet the requirements of ISO 13485 and the development of state-of-the-art medical technology, including surgical robotics, active implants, imaging software and AI.
The post holders will be part of a growing Quality and Regulatory Team and provide guidance to project teams on regulatory strategy and planning, quality system procedures, identifying gaps in project information and processes; recommending solutions, and be responsible for developing and maintaining compliant processes and technical documentation that meet the needs of the different stakeholders within and external to the organisation.
This is a full time (35 Hours per week), and you will be offered a fixed term contract for 2 years.
Senior Quality and Regulatory Engineer – Medical Devices - Strand, London, WC2R 2LS employer: King's College London
Contact Detail:
King's College London Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality and Regulatory Engineer – Medical Devices - Strand, London, WC2R 2LS
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by practising common questions related to quality and regulatory processes. We recommend doing mock interviews with friends or mentors to boost your confidence and refine your answers.
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work, especially projects involving ISO 13485 or software as a medical device. We love seeing tangible evidence of your skills in action.
✨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 of engineering better health for patients worldwide.
We think you need these skills to ace Senior Quality and Regulatory Engineer – Medical Devices - Strand, London, WC2R 2LS
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Quality and Regulatory Engineer role. Highlight your experience with medical devices, regulatory affairs, and quality management systems. We want to see how your skills align with our mission!
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 makes you a perfect fit for our team. Let us know what excites you about working with us at King's College London.
Showcase Relevant Experience: When detailing your experience, focus on specific projects or roles that relate to software as a medical device, design controls, or ISO 13485. We love seeing concrete examples of how you've contributed to similar projects in the past!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen to join our innovative team at the London Institute for Healthcare Engineering.
How to prepare for a job interview at King's College London
✨Know Your Regulations
Make sure you brush up on the key regulations like ISO 13485 and IEC 60601. Being able to discuss how these standards apply to your previous work will show that you’re not just familiar with them, but that you can also implement them effectively.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully navigated regulatory processes or implemented quality management systems. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Understand the Company’s Mission
Familiarise yourself with the mission of the London Institute for Healthcare Engineering and their focus on translating technologies to the clinic. Be ready to discuss how your skills and experiences align with their goals and how you can contribute to their projects.
✨Ask Insightful Questions
Prepare thoughtful questions about the role and the team dynamics. Inquire about the types of projects you might be involved in or how the Quality and Regulatory Team collaborates with other departments. This shows your genuine interest and helps you gauge if it’s the right fit for you.
