Senior Quality and Regulatory Specialist/Engineer – Medical Devices

King's College London; Greater London; On-site; GBP 55,000 - 90,000; Full time

Job summary

King's College London is seeking experts in medical device design regulatory processes to translate novel technologies to the clinic. The role supports MedTech Venture Builder and Accelerator programs, developing class I to III devices and ensuring ISO 13485 QMS compliance.

Based in LIHE, School of Biomedical Engineering and Imaging Sciences, you will guide project teams on regulatory strategy, quality systems, and documentation, while coordinating with start-ups and external stakeholders.

Qualifications

• Degree or equivalent experience in engineering discipline (biomedical, software, electronic, mechanical, materials), quality or related subject.
• Knowledge of applying quality system standards and regulation (ISO 13485, 21 CFR 820, AIMD, MDD/MDR).
• Experience applying design controls and risk management to medical devices or SaMD.
• Ability to understand regulatory needs and provide strategic advice for multiple medical device types.
• Experience applying quality system procedures; experience preparing SOPs, templates, test methods.

Responsibilities

• Provide guidance on regulatory strategy and planning for medical devices and SaMD.
• Develop and maintain compliant processes and technical documentation per stakeholders.
• Operate within QMS meeting ISO 13485 and relevant standards.
• Support regulatory submissions and quality system procedures; identify gaps and propose solutions.
• Collaborate with project teams and start-ups in MedTech Venture Builder and Accelerator.

Skills

Quality management

Regulatory strategy

Design controls

ISO 13485

MDR/MDD

Regulatory submissions

Auditing

SaMD development

Regulatory affairs for MedTech

Documentation

Project prioritisation

Team collaboration

ISO 62366-1

IEC 62304

IEC 60601 series

ISO 10993

Education

Degree or equivalent in engineering or related quality/regulatory field

Job description

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 role and you will be offered a fixed term contract for 2 years with the view to extend.

About You

To be successful in this role, we are looking for candidates to have the following skills and experience:

• Degree or equivalent experience in engineering discipline (biomedical, software, electronic, mechanical, materials), quality or related subject.
• Knowledge and experience of applying 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.
• Ability to understand regulatory needs and provide strategic advice for multiple medical device types.
• Experience of working to quality system procedures.
• Experience of preparing and writing standard operating procedures, templates and/or test method instructions.
• Experience of project or task prioritisation, able to handle several projects at once and work collaboratively with different teams to agreed deadlines.
• Excellent organisational, written and verbal communication skills and ability to troubleshoot.
• 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 medical device software