Quality assurance medical devices Work, Jobs in London (with Salaries)

Fractional Regulatory Affairs & Quality Manager – Medical Devices / IVD
Mitra Bio —London
- Part-time
1h
Quality Assurance Engineer
Cerebra —Tadworth
- £40,935 a year
- Full-time
- Continuous improvement
- Quality control
- In-person
- Annual leave
- Sick pay
Quick apply
20h
Medical Devices Safety Officer
Central and North West London NHS Foundation Trust —London
- £66,274 - £73,496 a year
- Full-time
- Continuous improvement
- Budgeting
7d
Clinical Evidence Analyst
BMJ —London
- From £56,626 a year
- Hybrid work
- Presentation skills
- Bachelor's degree
- Computer skills
- Employee discount
Quick apply
1d
Quality Assurance & Regulatory Affairs Executive - Maternity Cover
TensCare Ltd —Epsom
- £35,000 - £42,500 a year
- Temporary
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Team management
- Profit sharing
- Work from home
Quick apply
8d
Senior Research Executive-Custom Healthcare research
Ipsos —London
- Microsoft Powerpoint
- Writing skills
- Data analysis skills
- Annual leave
Operations Associate
Incite —London
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Writing skills
Quick apply
LETCHMORE HEATH SUBSTATION - DOCUMENT CONTROLLER
Laing O'Rourke —London
- Communication skills
Manager, Software Quality Assurance (Salesforce and Integrations)
Insulet Corporation —London
- Full-time
- Salesforce
- AI
- Leadership
Head of Computerized Systems Quality Assurance & Validation
IXICO —London
- Full-time
- Hybrid work
- Machine learning
- AI
- Communication skills
- Annual leave
- Employee assistance programme
6d
Scientist - £34,183 p.a. + benefits
Medicines and Healthcare Products Regulatory Agency —South Mimms
- £34,183 a year
- Full-time
- Laboratory experience
- Presentation skills
- Bachelor's degree
- Annual leave
- Sick pay
10d
Verification Test Engineer
CoMind —London
- £46,771 - £65,000 a year
- Full-time
- Analysis skills
- In-person
- Employee discount
8d
Healthcare Product Owner
Genomics —London
- Full-time
- Hybrid work
- Annual leave
Associate Quality Lead
Roche —Welwyn
- English
- Bachelor's degree
- Continuous improvement
Technical Customer Service Advisor
Utility Warehouse —London
- £26,850 a year
- Full-time
- Remote
- Employee assistance programme
- Employee discount
Quick apply
Product Training Consultant
Evac+Chair —Croydon
- £36,000 a year
- Full-time
- CRM software
- Microsoft Outlook
- Customer service
- Employee discount
- Life insurance
Quick apply
1d
Night Sterile Services Technician
HCA Healthcare UK —London
- £28,860 a year
- Full-time
- Hospital
- Employee discount
Digital Workplace IT Specialist
Sage —London
- £41,200 - £48,000 a year
- Remote
- Continuous improvement
- Annual leave
18h
Senior Optical Research Scientist
CoMind —London
- £58,000 - £81,000 a year
- Full-time
- Doctoral degree
- AI
- Communication skills
- Employee discount
Supplier Quality Assurance Manager
Humanoid —London
- Full-time
- Master's degree
- Continuous improvement
- Quality control
- Annual leave
Quick apply

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Fractional Regulatory Affairs & Quality Manager – Medical Devices / IVD

Mitra Bio
London

Apply Now

Job details

Part-time | Fixed term contract
1 hour ago

Qualifications

Complaint handling
Quality assurance
Technical writing
Quality management system (QMS) implementation
ISO 13485
Corporate regulatory compliance oversight
FDA regulations
Category C Licence

Full job description

London based, Hybrid.

August 14, 2026

12-month fixed-term contract | Part-time, 3 days per week | London preferred

Company description

Mitra Bio has developed a non-invasive skin sampling that can detect molecular changes in the skin non-invasively. The Company has been awarded the prestigious European Innovation Council grant to develop a non-invasive molecular test for screening moles suspected of melanoma.

As we continue to grow, we’re looking for a Fractional Regulatory Affairs & Quality Manager – Medical Devices / IVD to lead our regulatory and quality activities for our melanoma diagnostic programme and support the successful launch of our medical device and diagnostic products in the UK and EU.

This is a 12-month fixed-term contract, working three days per week, with the opportunity to increase the commitment as the programme develops.

Role description

You’ll lead the regulatory and quality activities for Mitra Bio’s melanoma diagnostic programme, which includes a non-invasive sampling medical device and a next-generation sequencing-based molecular test for cancer.

This is a hands-on role for someone who has previously taken a medical device or IVD through regulatory approval and to market. You’ll lead the preparation of technical documentation and regulatory submissions, develop and maintain our Quality Management System, and act as Mitra Bio’s key regulatory contact with external regulatory bodies and partners.

You’ll work closely with our product, scientific and clinical teams to ensure regulatory requirements are incorporated throughout product development and that our clinical and analytical evidence meets submission requirements.

You’ll be responsible for:

Leading the regulatory activities to achieve CE marking of Mitra Bio’s melanoma diagnostic test and sampling device in compliance with IVDR and MDR
Developing, implementing and maintaining Mitra Bio’s Quality Management System in accordance with ISO 13485
Leading preparation of technical documentation and regulatory submissions under applicable UK and EU medical device and IVD regulations
Managing interactions with relevant regulatory authorities, UK Approved Bodies, EU Notified Bodies and other external regulatory partners
Leading or supporting product and organisational registrations, including EUDAMED and relevant UK requirements
Providing regulatory oversight of verification and validation activities, ensuring clinical and analytical evidence meets submission requirements
Establishing appropriate post-market surveillance, complaints handling and regulatory reporting processes
Advising product, scientific and clinical teams on regulatory requirements throughout product development
Ensuring regulatory requirements are translated into practical development plans, documentation and milestones

London is preferred.

About you

You’re an experienced Regulatory Affairs and/or Quality Assurance professional with a strong background in IVDs and hands-on experience taking medical devices or IVDs through regulatory approval.

You have strong working knowledge of EU MDR and/or IVDR and ISO 13485, and you’re comfortable taking hands-on ownership of regulatory and quality activities.

You should apply if you have:

Significant professional experience in Regulatory Affairs and/or Quality Assurance within the IVD industry
Hands-on experience with EU medical device regulatory approvals and CE marking under EU MDR and/or IVDR, with preference for experience with high-complexity Class C IVDs
Strong working knowledge of ISO 13485 and medical device quality management systems
Experience preparing and managing technical documentation and regulatory submissions
Experience working directly with regulatory authorities, Approved Bodies and/or Notified Bodies
Strong understanding of verification, validation, clinical evidence and post-market requirements
The ability to operate independently in an early-stage startup environment and take ownership from strategy through execution

It would be particularly useful if you also have:

EUDAMED registration experience
Experience with FDA regulatory pathways, including pre-submission meetings and/or 510(k) submissions
Familiarity with genomics, next-generation sequencing or molecular diagnostic workflows
Experience establishing or scaling a QMS within an early-stage biotechnology or diagnostics company

Mitra Bio is committed to building a diverse and inclusive team, and we welcome applications from people of all backgrounds, experiences and perspectives.

Interested? Please submit your CV along with a brief note telling us why you’re interested in the role and working with Mitra Bio.

Apply Now

Refine Your Search

quality assurance medical devices jobs in london

Fractional Regulatory Affairs & Quality Manager – Medical Devices / IVD

Quality Assurance Engineer

Medical Devices Safety Officer

Clinical Evidence Analyst

Quality Assurance & Regulatory Affairs Executive - Maternity Cover

Senior Research Executive-Custom Healthcare research

Operations Associate

LETCHMORE HEATH SUBSTATION - DOCUMENT CONTROLLER

Manager, Software Quality Assurance (Salesforce and Integrations)

Head of Computerized Systems Quality Assurance & Validation

Scientist - £34,183 p.a. + benefits

Verification Test Engineer

Healthcare Product Owner

Associate Quality Lead

Technical Customer Service Advisor

Product Training Consultant

Night Sterile Services Technician

Digital Workplace IT Specialist

Senior Optical Research Scientist

Supplier Quality Assurance Manager

I want to receive the latest job alerts for quality assurance medical devices in london

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