Clinical documentation specialist Work, Jobs in Eng (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
QA Specialist
MedPharm —Guildford
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
Clinical Systems Specialist
Alliance Medical Ltd —Warwick
- £45,000 a year
- Full-time
- Remote
- Continuous improvement
- Organisational skills
- Communication skills
Quick apply
Bank Medical Records Administrator
Spire Healthcare —Sutton Coldfield
- Computer literacy
- Computer skills
- Communication skills
- Free parking
- Annual leave
6d
Clinical Support Specialist - 12 month FTC, Full-Time
hVIVO Services Limited —London
- Overtime
- Customer service
- Communication skills
- Annual leave
- Employee assistance programme
Freelance Site Activation Specialist (Study Start-Up / Regulatory Submissions) – UK Remote
IQVIA —London
- Full-time
- Remote
- English
- Bachelor's degree
- Communication skills
- Work from home
2d
Senior Clinical Trials Coordinator
The Christie NHS Foundation Trust —Manchester
- £32,073 - £39,043 a year
- Full-time
- Training & development
- Leadership
- Communication skills
5d
Project Specialist
WEP Clinical —London
- Full-time
- Hybrid work
- Computer literacy
- Bachelor's degree
- Data entry
- Employee assistance programme
16h
Application Support Specialist
Collinson —London
- Hybrid work
- Computer Science
- Customer service
- DevOps
Junior Quality System Specialist
Loftware, Inc. —Reading
- £25,000 - £39,000 a year
- Hybrid work
- Engineering
- English
- Bachelor's degree
Quick apply
Information Security Specialist
DeepHealth —London
- £55,000 - £75,000 a year
- Full-time
- Remote
- Computer Science
- Master's degree
- Bachelor's degree
Quick apply
Patient Care Coordinator in Luxury Private Hospital
Berkshire Grove Hospital —Maidenhead
- £14 - £16 an hour
- Full-time
- Administrative experience
- Data entry
- Organisational skills
- Free parking
Quick apply
Senior Clinical Research Specialist
Medtronic —London
- £50,400 - £91,200 a year
- Full-time
- English
- Bachelor's degree
- Travel
5d
Application Development & Support Analyst
Harris Fowler Ltd —Taunton
- Full-time
- Hybrid work
- Databases
- SQL
- Scripting
- Health & wellbeing programme
Quick apply
Clinical Data & Device Specialist
SAVA —London
Quick apply
Clinical Research Technician
Cambridgeshire and Peterborough NHS Foundation Trust —Cambridge
- £28,392 - £31,157 a year
- Full-time
- Patient care
2d
Clinical Research Practitioner
The Christie NHS Foundation Trust —Manchester
- £32,073 - £39,043 a year
- Full-time
- Patient care
- Data entry
- Organisational skills
2d
Clinical Systems Application Specialist
Mersey and West Lancashire Teaching Hospitals NHS Trust —St Helens
- £39,959 - £48,117 a year
- Full-time
- Analysis skills
- Organisational skills
- Typing
3d
Allied Health, HCPC & Diagnostic Professionals
Edgbaston Wellness Clinic & Quarry Bank Medical Centre —Birmingham
- £26,484.15 - £77,962.16 a year
- Full-time
- Patient monitoring
- BLS Certification
- English
- Profit sharing
- Health & wellbeing programme
Quick apply
8d
Clinical Independent Rater for Clinical Trial - Polish Speaking
IQVIA —Portishead
- £104,600 - £194,200 a year
- Part-time
- Remote
- Doctoral degree
- English
- Master's degree
- Work from home
3d

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clinical documentation specialist jobs near eng

Medical Device Regulatory Affairs Specialist

Clinica Engineering Medical Solutions Ltd
Reading

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Job details

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

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

clinical documentation specialist jobs in eng

Medical Device Regulatory Affairs Specialist

QA Specialist

Clinical Systems Specialist

Bank Medical Records Administrator

Clinical Support Specialist - 12 month FTC, Full-Time

Freelance Site Activation Specialist (Study Start-Up / Regulatory Submissions) – UK Remote

Senior Clinical Trials Coordinator

Project Specialist

Application Support Specialist

Junior Quality System Specialist

Information Security Specialist

Patient Care Coordinator in Luxury Private Hospital

Senior Clinical Research Specialist

Application Development & Support Analyst

Clinical Data & Device Specialist

Clinical Research Technician

Clinical Research Practitioner

Clinical Systems Application Specialist

Allied Health, HCPC & Diagnostic Professionals

Clinical Independent Rater for Clinical Trial - Polish Speaking

I want to receive the latest job alerts for clinical documentation specialist in eng

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