Software quality assurance specialist Work, Jobs in Maidenhead, Brk (with Salaries)

Medical Device Regulatory Affairs Specialist
Clinica Engineering Medical Solutions Ltd —Reading
- £3,700 - £4,200 a month
- Full-time
- Engineering
- English
- Databases
Quick apply
2d
Software Engineer
Pexip —Reading
- Full-time
- Computer networking
- In-person
- Work from home
Quick apply
Systems Engineer
Leidos —Farnborough
- £47,600 - £61,000 a year
- Full-time
- System design
- Organisational skills
- Agile
- Annual leave
- Work from home
3d
Graduate Engineering Geologist
Fugro —Wallingford
- Full-time
- Engineering
- Leadership
- Communication skills
- Referral programme
Lead Design Quality Assurance Engineer - 12m Inside IR35 Contractor
Safran Engineering Services UK Limited —Pitstone
- Engineering
- Analysis skills
- Bachelor's degree
Quick apply
Systems Engineer (System Design Specialist)
Leidos —Farnborough
- £47,600 - £61,000 a year
- Full-time
- System design
- Organisational skills
- Agile
- Annual leave
- Work from home
APQP Specialist - 12m Inside IR35 Contractor
Safran Engineering Services UK Limited —Pitstone
- Engineering
- Analysis skills
- Bachelor's degree
Quick apply
Civil Engineer (Water)
J&T Business Consulting —Slough
- £45,000 - £85,000 a year
- Civil engineering
- Engineering
- Master's degree
Quick apply
4d
Assistant practice manager
Kerban Projects —London
- From £15 an hour
- Part-time
- English
- Microsoft Office
- Administrative experience
Quick apply
12d
Production / Electromechanical Build Technician
QinetiQ —Farnborough
- £32,175 - £35,750 a year
- Full-time
- Employee discount
4d
Credit Controller
Lucy Electric —Thame
- Hybrid work
- Customer service
- Computer literacy
- Data entry
Graphic Designer
Berkeley Group —Fulham
- Microsoft Powerpoint
- Microsoft Word
- Organisational skills
- Annual leave
Quick apply
Project Manager (Maritime, London)
4C Strategies —London
- Hybrid work
- PMP
- Business development
- Project management
Senior Generalist & Physics Engineer
Stellar Entertainment Software Ltd —Guildford
- Full-time
- Hybrid work
- C++
- Communication skills
- Employee assistance programme
Quick apply
Data Analytics & AI Solutions Group Leader
UL Solutions —Basingstoke
- Remote
- Computer Science
- Master's degree
- Bachelor's degree
- Annual leave
Technical Cloud Lead (Azure)
PEXA Group —Thame
- £75,000 - £80,000 a year
- Hybrid work
- Azure
- Communication skills
- Annual leave
- Employee assistance programme
Quick apply
3d
Technical Director
Supermassive Games —Guildford
- Team management
- Conflict management
- Mentoring
- Annual leave
- Employee assistance programme
Senior Consultant / Consultant - Geospatial and Data Analytics
Steer —Hemel Hempstead
- £35,000 - £45,000 a year
- Full-time
- Hybrid work
- Analysis skills
- Annual leave
- Employee assistance programme
Quick apply
10d
Senior Estimator
Kier Group —London
- Part-time
- Organisational skills
- Construction experience
- Flexible schedule
Senior Systems Engineer
Stellar Entertainment Software Ltd —Guildford
- Full-time
- Hybrid work
- Software troubleshooting
- C++
- Employee assistance programme
Quick apply

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Medical Device Regulatory Affairs Specialist

Clinica Engineering Medical Solutions Ltd
Reading

Quick apply

Job details

Permanent | Full-time
£3,700 - £4,200 a month
2 days ago

Qualifications

Document control
Record keeping
Labelling
Engineering
Filing
Corrective and preventive actions (CAPA)
English
Complaint handling
Databases
Compliance monitoring
Quality assurance
Risk management
Technical writing
English
Cybersecurity
Document management
Communication skills
ISO 13485
Corporate regulatory compliance oversight

Full job description

About the Role

Clinica Engineering Medical Solutions Ltd is looking for a Medical Device Regulatory Affairs Specialist to join our team at Green Park Business Park in Reading. You will support the registration, regulatory compliance, and ongoing market approval of medical devices and healthcare technology solutions.

This role is suited to a detail-oriented regulatory professional who understands how technical documentation, quality standards, clinical evidence, and regulatory requirements contribute to safe and compliant medical products. You will work closely with engineering, quality assurance, clinical, product development, and commercial teams throughout the product lifecycle.

Key Responsibilities

Prepare, review, and maintain regulatory documentation for medical devices and healthcare technology products.
Support product registrations, licence applications, and regulatory submissions in the United Kingdom and other relevant markets.
Assist with UKCA and CE-marking activities for applicable medical devices.
Maintain technical files, declarations of conformity, product classifications, and supporting documentation.
Review product specifications, labelling, instructions for use, and promotional materials for regulatory compliance.
Monitor changes to medical-device regulations, standards, and regulatory guidance.
Conduct regulatory assessments for product modifications, software updates, and manufacturing changes.
Support post-market surveillance and vigilance reporting activities.
Assist with the investigation and documentation of complaints, adverse events, and field safety issues.
Work with engineering teams to ensure regulatory requirements are considered during product development.
Support internal and external regulatory inspections and quality audits.
Maintain accurate regulatory submission records, approval documents, and compliance databases.
Coordinate with authorised representatives, notified bodies, external consultants, and regulatory authorities.
Contribute to risk-management activities and the preparation of product risk documentation.
Provide regulatory guidance to internal teams regarding new and existing products.

What We Are Looking For

At least 2–4 years of experience in medical-device regulatory affairs, quality assurance, pharmaceutical compliance, or a related field.
Good understanding of United Kingdom medical-device regulations.
Familiarity with UKCA marking, CE marking, and medical-device classification requirements.
Experience preparing or maintaining technical documentation for regulated products.
Knowledge of quality-management systems and regulatory documentation controls.
Understanding of ISO 13485 and medical-device risk-management principles.
Ability to interpret complex regulatory standards and communicate requirements clearly.
Strong written communication and technical documentation skills.
Excellent organisation, accuracy, and attention to detail.
Ability to manage several submissions, documentation projects, and deadlines simultaneously.
Strong written and spoken English.
A degree in biomedical engineering, life sciences, pharmacy, healthcare technology, regulatory affairs, or a related discipline is preferred.

Preferred Skills

Experience working with software as a medical device or digitally connected healthcare products.
Knowledge of ISO 14971 risk-management requirements.
Familiarity with clinical evaluations and post-market clinical follow-up documentation.
Experience supporting regulatory submissions outside the United Kingdom.
Knowledge of European Union Medical Device Regulation requirements.
Familiarity with corrective and preventive action processes.
Experience participating in notified-body, regulatory-authority, or customer audits.
Professional certification or additional training in medical-device regulatory affairs.
Understanding of data-protection and cybersecurity requirements for connected medical devices.

Mindset

You are methodical, responsible, and comfortable working in a highly regulated environment. You understand that incomplete documentation or overlooked regulatory details can affect product approval, patient safety, and commercial operations.

You take ownership of your work, raise potential compliance issues early, and communicate regulatory requirements clearly to both technical and non-technical colleagues. You remain calm under deadlines and balance commercial priorities with the need to maintain high regulatory and ethical standards.

Pay: £3,700.00-£4,200.00 per month

Work Location: In person

Quick apply

Refine Your Search

software quality assurance specialist jobs in maidenhead, brk

Medical Device Regulatory Affairs Specialist

Software Engineer

Systems Engineer

Graduate Engineering Geologist

Lead Design Quality Assurance Engineer - 12m Inside IR35 Contractor

Systems Engineer (System Design Specialist)

APQP Specialist - 12m Inside IR35 Contractor

Civil Engineer (Water)

Assistant practice manager

Production / Electromechanical Build Technician

Credit Controller

Graphic Designer

Project Manager (Maritime, London)

Senior Generalist & Physics Engineer

Data Analytics & AI Solutions Group Leader

Technical Cloud Lead (Azure)

Technical Director

Senior Consultant / Consultant - Geospatial and Data Analytics

Senior Estimator

Senior Systems Engineer

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