Senior Quality and Regulatory Engineer – Medical Devices in London
Senior Quality and Regulatory Engineer – Medical Devices

Senior Quality and Regulatory Engineer – Medical Devices in London

London Full-Time 36000 - 60000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Support innovative medical device projects and ensure compliance with regulatory standards.
  • Company: Join a leading institute at King's College London focused on healthcare engineering.
  • 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 a focus on research and innovation in MedTech.

The predicted salary is between 36000 - 60000 £ 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.

Senior Quality and Regulatory Engineer – Medical Devices in London employer: KINGS COLLEGE LONDON

At King's College London, we pride ourselves on being an exceptional employer, offering a dynamic work environment within the London Institute for Healthcare Engineering. Our collaborative culture fosters innovation and professional growth, providing employees with unique opportunities to contribute to groundbreaking medical technologies while working alongside leading experts in the field. With a commitment to advancing healthcare through research and development, we ensure that our team members are supported in their career journeys, making a meaningful impact on patient outcomes worldwide.
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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 in London

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 researching the company and its projects. We recommend practising common interview questions related to quality management and regulatory affairs, so you can showcase your expertise confidently.

Tip Number 3

Showcase your skills through real-life examples. When discussing your experience with design controls or ISO 13485, we suggest using specific projects to illustrate your impact and problem-solving abilities.

Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are genuinely interested in joining our mission to engineer better health.

We think you need these skills to ace Senior Quality and Regulatory Engineer – Medical Devices in London

Medical Device Design
Regulatory Affairs
Software as a Medical Device
Design Controls
IEC 60601
Quality Management Implementation
ISO 13485
Medical Engineering Quality Management System (QMS)
Technical Documentation
Regulatory Strategy
Problem-Solving Skills
Collaboration
Stakeholder Engagement
Project Management

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 StudySmarter.

Showcase Relevant Experience: When detailing your experience, focus on specific projects or roles that relate to the job description. Mention any work with software as a medical device or design controls, as these are key areas for us in this position.

Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!

How to prepare for a job interview at KINGS COLLEGE LONDON

Know Your Regulations

Familiarise yourself with key regulations like ISO 13485 and IEC 60601. Be ready to discuss how you've applied these standards in your previous roles, especially in the context of medical devices.

Showcase Your Experience

Prepare specific examples from your past work that highlight your experience with Software as a Medical Device and Quality Management Implementation. Use the STAR method (Situation, Task, Action, Result) to structure your responses.

Understand the Company’s Mission

Research the London Institute for Healthcare Engineering and their projects. Be prepared to explain how your skills align with their mission of advancing healthcare technology and improving patient outcomes.

Ask Insightful Questions

Prepare thoughtful questions about the role and the team dynamics. Inquire about current projects or challenges they face in regulatory affairs, showing your genuine interest in contributing to their success.

Senior Quality and Regulatory Engineer – Medical Devices in London
KINGS COLLEGE LONDON
Location: London

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