Affairs specialist Work, Jobs in Reading, 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
Senior Regulatory Affairs Specialist
Kenvue —Reading
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
- Annual leave
Paralegal
EMG Solicitors —Reading
- Full-time
- Business development
- Organisational skills
- Time management
- Annual leave
- Employee assistance programme
Study Start Up Manager
Fortrea —Maidenhead
- Full-time
- Remote
- English
- Bachelor's degree
14d
Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Databases
- Bachelor's degree
- Annual leave
Freelance Site Activation Specialist (Study Start-Up / Regulatory Submissions) – UK Remote
IQVIA —Oxford
- Full-time
- Remote
- English
- Bachelor's degree
- Communication skills
- Work from home
1d
Press Officer
Dynamic Planner —Reading
- Full-time
- Hybrid work
- Financial services
- AI
- Internship
13d
Researcher in Reproductive Demography
University of Oxford —Oxford
- £39,424 - £47,779 a year
- Full-time
- Doctoral degree
- Research
- Communication skills
Therapy Specialist - Advanced Surgery South
Baxter —Reading
- CRM software
- Sales
- English
- Annual leave
1d
Solicitor - Court of Protection (Property & Affairs)
EMG Solicitors —Reading
- Full-time
- Hybrid work
- Business development
- Organisational skills
- Time management
- Annual leave
- Employee assistance programme
Product Stewardship & Regulatory Specialist - EMEA
Axalta Coat. Sys. UK —Farnham
- English
- Microsoft Office
- Bachelor's degree
- Annual leave
Quick apply
5d
Practice Area Lead: Medical Affairs Communications
IQVIA —Reading
- Full-time
- Hybrid work
- Business development
- Training & development
- Leadership
Specialist/Snr Specialist Study Start Up and Regulatory Affairs
Ergomed —Guildford
- Full-time
- Remote
- Nursing
- No degree
- Quality control
Quick apply
15h
Senior Process Quality Excellence Specialist
UCB —Slough
- English
- Analysis skills
- Bachelor's degree
9d
Science Evidence Project Manager (ID4831)
Animal and Plant Health Agency —New Haw
- £38,795 a year
- Overtime
- Analysis skills
- Presentation skills
- Bachelor's degree
- Annual leave
- Employee discount
12d
ESG Compliance Manager
The Entertainer —Amersham
- £65,000 - £70,000 a year
- Full-time
- Project management
- No degree
Country Medical Director, UK and Ireland
Gilead Sciences —London
- Full-time
- Hybrid work
- Management
- Research
- Recruiting
Associate Director, Private Capital Corporate Tax
Grant Thornton UK LLP —Reading
- Full-time
- Business development
- Tax experience
- Employee discount
Consultant Dermatologist
Hampshire Hospitals NHS Foundation Trust —Basingstoke
- £113,565 - £150,569 a year
- Full-time
7d
Senior Animal Technologist (ID4838)
Animal and Plant Health Agency —New Haw
- £38,795 a year
- Overtime
- Microsoft Outlook
- Doctoral degree
- English
- Annual leave
- Employee discount
7d

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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

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

affairs specialist jobs in reading, eng

Medical Device Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Paralegal

Study Start Up Manager

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

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

Press Officer

Researcher in Reproductive Demography

Therapy Specialist - Advanced Surgery South

Solicitor - Court of Protection (Property & Affairs)

Product Stewardship & Regulatory Specialist - EMEA

Practice Area Lead: Medical Affairs Communications

Specialist/Snr Specialist Study Start Up and Regulatory Affairs

Senior Process Quality Excellence Specialist

Science Evidence Project Manager (ID4831)

ESG Compliance Manager

Country Medical Director, UK and Ireland

Associate Director, Private Capital Corporate Tax

Consultant Dermatologist

Senior Animal Technologist (ID4838)

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