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- 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: Fixed-term contract, inclusive culture, and opportunities for professional growth.
- Why this job: Make a real difference in healthcare by working on cutting-edge medical technologies.
- Qualifications: Degree in engineering or related field with experience in quality systems and regulations.
- Other info: Collaborative environment with diverse projects and a focus on advancing health technology.
The predicted salary is between 43200 - 72000 £ per year.
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.
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.
Essential criteria
- Degree or equivalent experience in engineering discipline (biomedical, software, electronic, mechanical, materials), quality or related subject.
- Knowledge of quality system standards and regulation, e.g. ISO 13485, 21 CFR 820, AIMD, MDD and MDR.
- Experience in the application of design controls and risk management to medical device or SaMD design activities, e.g. writing or reviewing design plans, requirements, hazard analysis, verification and validation protocols and reports.
- Experience of working to quality system procedures.
- Contributed to standard operating procedures, templates and/or test method instructions.
- Excellent organisational, written and verbal communication skills and ability to troubleshoot.
Additional essential criteria
- Knowledge and experience applying quality system standards and regulation, e.g. ISO 13485, 21 CFR 820, AIMD, MDD and MDR.
- Ability to understand regulatory needs and provide strategic advice for multiple medical device types.
- Experience of project or task prioritisation, able to handle several projects at once and work collaboratively with different teams to agreed deadlines.
- Experience of preparing and writing standard operating procedures, templates and/or test method instructions.
Desirable criteria
- Knowledge and experience of development and testing standards applied to medical devices e.g. ISO 62366-1, IEC 62304, IEC 60601 series, or ISO 10993 series.
- Auditing experience
- Experience in preparing regulatory submissions
- Experience in working with early-stage companies, where requirements are not clearly defined and where flexibility is needed
- Prior experience in the development, regulation, or quality management of combination products
We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.
We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's.
We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.
To find out how our managers will review your application, please take a look at our "How we Recruit" pages.
Senior Quality and Regulatory Engineer - Medical Devices employer: KINGS COLLEGE LONDON
Contact Detail:
KINGS COLLEGE LONDON Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality and Regulatory Engineer - Medical Devices
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Show them you’re not just another candidate; you’re genuinely interested in their mission and how you can contribute to it.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to quality management and regulatory affairs. Being articulate about your experience will set you apart from the competition.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Quality and Regulatory Engineer - Medical Devices
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in medical device design and regulatory processes. We want to see how your skills align with the essential criteria, so don’t hold back on showcasing your relevant achievements!
Craft a Compelling Supporting Statement: Your supporting statement is your chance to shine! Use it to detail how you meet the essential and desirable criteria. Be specific about your experiences and how they relate to the role – we love seeing real examples!
Showcase Your Communication Skills: Since excellent written communication is key for this role, make sure your application is clear and concise. We appreciate well-structured documents that are easy to read, so take your time to proofread before hitting send!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way to ensure your application gets to us directly. Plus, you’ll find all the info you need about the role and our team there!
How to prepare for a job interview at KINGS COLLEGE LONDON
✨Know Your Regulations
Make sure you brush up on the key regulations like ISO 13485 and 21 CFR 820. Be ready to discuss how you've applied these standards in your previous roles, especially in relation to medical devices. This shows that you not only understand the theory but can also implement it practically.
✨Showcase Your Experience with Design Controls
Prepare specific examples of how you've worked with design controls and risk management in medical device projects. Highlight any experience you have in writing or reviewing design plans and validation protocols. This will demonstrate your hands-on expertise and problem-solving skills.
✨Communicate Clearly
Since excellent communication is essential for this role, practice articulating your thoughts clearly and concisely. You might be asked to explain complex concepts, so being able to break them down into simpler terms will impress your interviewers.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific situations, such as identifying gaps in project information or recommending solutions. Think through some scenarios beforehand and prepare your responses to show your strategic thinking and collaborative approach.
