Regulatory specialist Work, Jobs in Slough, 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
4d
Research Regulatory Facilitator
Imperial College London —White City
- £48,246 - £58,318 a year
- Full-time
- University
- Time management
- Annual leave
10d
Business Analysts — All Levels - UK Wide
Concept AI Ltd —London
- £35,000 - £120,000 a year
- Full-time
- Hybrid work
- Engineering
- Analysis skills
- Bachelor's degree
- Flexitime
- Work from home
Quick apply
5d
QA Specialist
MedPharm —Guildford
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
Quick apply
Sr. Specialist, Regulatory Affairs
The Bountiful Company —Tring
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Outlook
Quick apply
Nutrition Specialist (Global Regulatory & Corporate Affairs)
Oatly AB —London
- Part-time
- Hybrid work
- English
- Research
- Master's degree
Quick apply
Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Databases
- Bachelor's degree
- Annual leave
Clinical Trials Coordinator
University College London —London
- £43,981 a year
- Full-time
- Hybrid work
11d
Medical Information Specialist - Afterhours
EVERSANA —London
- Weekend availability
- Remote
- Microsoft Word
- Computer literacy
- English
Quick apply
13d
Medical Information Specialist - US Hours
EVERSANA —London
- Full-time
- Remote
- Microsoft Word
- Computer literacy
- English
Quick apply
Senior Regulatory Affairs Specialist
Kenvue —Reading
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
- Annual leave
VodafoneThree - Health, Safety and Environmental Specialist
Vodafone —Farnborough
- Full-time
- Remote
- Computer literacy
- Travel
- Computer skills
- Employee discount
2d
QA Specialist - NPI
GE HEALTHCARE —Chalfont Saint Giles
- £56,000 - £77,000 a year
- Bachelor's degree
- Continuous improvement
- Travel
Sr. Drug Safety Specialist
GE HEALTHCARE —Chalfont Saint Giles
- Microsoft Word
- Data entry
Clinical Evaluation Specialist
Scarlet —London
- £75,000 - £90,000 a year
- Full-time
- Nursing
- Software development
- Communication skills
Clinical Trials Coordinator part time 0.5 FTE
University College London —London
- £21,990.50 a year
- Part-time
- Hybrid work
11d
FSQRN Data & Analytics Specialist
Starbucks —London
- Full-time
- Analysis skills
6d
Specialist Biomedical Scientist – Haematology
HCA Healthcare UK —London
- Overtime
- Laboratory experience
- Quality control
- Organisational skills
- Employee discount
Regulatory Change Implementation Specialist - 2026
Suade —London
- £50,000 - £75,000 a year
- Full-time
- Hybrid work
- English
- Bachelor's degree
- Mentoring
- Annual leave
- Work from home
Quick apply
Global Benefits Senior Specialist
Boston Consulting Group —London
- Full-time
- Microsoft Excel
- Data analysis skills
- Analysis skills

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regulatory specialist jobs near slough, brk

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
4 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

regulatory specialist jobs in slough, brk

Medical Device Regulatory Affairs Specialist

Research Regulatory Facilitator

Business Analysts — All Levels - UK Wide

QA Specialist

Sr. Specialist, Regulatory Affairs

Nutrition Specialist (Global Regulatory & Corporate Affairs)

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Clinical Trials Coordinator

Medical Information Specialist - Afterhours

Medical Information Specialist - US Hours

Senior Regulatory Affairs Specialist

VodafoneThree - Health, Safety and Environmental Specialist

QA Specialist - NPI

Sr. Drug Safety Specialist

Clinical Evaluation Specialist

Clinical Trials Coordinator part time 0.5 FTE

FSQRN Data & Analytics Specialist

Specialist Biomedical Scientist – Haematology

Regulatory Change Implementation Specialist - 2026

Global Benefits Senior Specialist

I want to receive the latest job alerts for regulatory specialist in slough, brk

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