KINGS COLLEGE LONDON: Senior High quality and Regulatory Specialist – Medical Gadgets

About us

We’re in search of specialists in medical system design regulatory processes to hitch our staff and work with mission teams to translate novel applied sciences to the clinic.

We welcome functions from people with expertise in:

• Regulatory Affairs supporting MedTech start-up organisations
• High quality Administration Implementation
• Software program as a Medical Machine

The publish holders can be based mostly within the London Institute for Healthcare Engineering (LIHE) a part of the Faculty of Biomedical Engineering and Imaging Sciences, King’s Faculty London.

Concerning the function

Positioned inside a hospital surroundings, our mission is to generate tangible medical and business translation via our stimulating collaborations to realize the sudden, and advance research, innovation and teaching progress via our shared mission of engineering higher health for sufferers worldwide.

The publish holders will help all kinds of research tasks within the Faculty and start-up corporations as a part of our MedTech Enterprise Builder and Accelerator programmes within the MedTech and Digital Well being Hubs to develop new class I to class III medical units and healthcare technology.

They are going to function throughout the Medical Engineering High quality Administration System (QMS), developed to satisfy the necessities of ISO 13485 and the event of state-of-the-art medical technology, together with surgical robotics, lively implants, imaging software program and AI.

The publish holders can be a part of a rising High quality and Regulatory Group and supply steering to mission groups on regulatory strategy and planning, high quality system procedures, figuring out gaps in mission data and processes; recommending options, and be answerable for creating and sustaining compliant processes and technical documentation that meet the wants of the completely different stakeholders inside and exterior to the organisation.

This can be a full time publish (35 Hours per week), and you can be provided a hard and fast time period contract till 30 September 2026.

About You

To achieve success on this function, we’re in search of candidates to have the next expertise and expertise:

Important standards

1. Diploma or equal expertise in engineering self-discipline (biomedical, software program, digital, mechanical, supplies), high quality or associated topic.
2. Information and expertise making use of high quality system requirements and regulation, e.g. ISO 13485, 21 CFR 820, AIMD, MDD and MDR.
3. Expertise within the utility of design controls and risk management to medical system or SaMD design actions, e.g. writing or reviewing design plans, necessities, hazard evaluation, verification and validation protocols and experiences.
4. Means to grasp regulatory wants and supply strategic recommendation.
5. Expertise of working to high quality system procedures.
6. Expertise of making ready and writing normal working procedures, templates and/or check methodology directions.
7. Expertise of mission or job prioritisation, capable of deal with a number of tasks without delay and work collaboratively with completely different groups to agreed deadlines.
8. Glorious organisational, written and verbal communication skills and talent to troubleshoot.

Fascinating standards

1. Information and expertise of growth and testing requirements utilized to medical units e.g. ISO 62366, IEC 62304, IEC 60601 collection, or ISO 10993 collection.
2. Auditing expertise
3. Expertise in making ready regulatory submissions
4. Expertise in working with early-stage corporations, the place necessities should not clearly outlined and the place flexibility is required

Full particulars of the function and the talents and expertise required will be discovered within the hooked up job description which is offered on the following web page.

Additional data

We delight ourselves on being inclusive and welcoming. We embrace range and wish everybody to really feel that they belong and are linked to others in our community.

We’re dedicated to working with our workers and unions on these and different points, to proceed to help our individuals and to develop a various and inclusive tradition at King’s.

We ask all candidates to submit a duplicate of their CV, and a supporting assertion, detailing how they meet the important standards listed within the advert. If we obtain a powerful discipline of candidates, we could use the fascinating standards to decide on our last shortlist, so please embrace your proof towards these the place doable.

To learn the way our managers evaluate your utility, please check out our ‘How we Recruit’ pages.