Regulatory affairs specialist Work, Jobs in Middlesex, Gtl (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
Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Databases
- Bachelor's degree
- Annual leave
Nutrition Specialist (Global Regulatory & Corporate Affairs)
Oatly AB —London
- Part-time
- Hybrid work
- English
- Research
- Master's degree
Quick apply
Sr. Specialist, Regulatory Affairs
The Bountiful Company —Tring
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Outlook
Quick apply
Senior Regulatory Affairs Specialist
Kenvue —Reading
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
- Annual leave
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
Regulatory Reporting Industrial Placement - September 2026
Buzzacott —London
- Microsoft Word
- Computer Science
- Organisational skills
5d
Sr. Drug Safety Specialist
GE HEALTHCARE —Chalfont Saint Giles
- Microsoft Word
- Data entry
Senior Manager – ESG and Sustainability Regulatory Legal
Pwc UK —London
- Full-time
- Hybrid work
- Business development
- Analysis skills
- Presentation skills
Expert Consultant – Healthcare | Safety, Risk & Regulatory
Boston Consulting Group —London
- Full-time
- Doctoral degree
- Master's degree
- Business development
9d
Medical Affairs Advisor
GlaxoSmithKline —London
- Full-time
- Databases
- Leadership
12d
Clinical Data & Device Specialist
SAVA —London
Quick apply
Consultant
Milltown Partners —London
- £46,000 - £69,000 a year
- Full-time
- Hybrid work
- AI
Director - Regulatory Affairs Lifecycle Management Non-Medicines
Perrigo —London
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Team management
3d
Medical Information Specialist - Spanish & English speaking
EVERSANA —London
- Full-time
- Remote
- Microsoft Word
- Spanish
- Computer literacy
Quick apply
7d
Director - Regulatory Affairs Lifecycle Management Medicines
Perrigo —London
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Team management
3d
Regulatory Market Access Lead
Viasat, Inc. —London
- Full-time
- Communication skills
Medical Information Specialist - German & English speaking
EVERSANA —London
- Full-time
- Remote
- Microsoft Word
- Computer literacy
- English
Quick apply
Director, Government Affairs and Advocacy - Europe and International
GlaxoSmithKline —London
- Full-time
- Bachelor's degree
- Team management
- Travel

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regulatory affairs specialist jobs near middlesex, gtl

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

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Refine Your Search

regulatory affairs specialist jobs in middlesex, gtl

Medical Device Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Nutrition Specialist (Global Regulatory & Corporate Affairs)

Sr. Specialist, Regulatory Affairs

Senior Regulatory Affairs Specialist

Medical Information Specialist - Afterhours

Medical Information Specialist - US Hours

Regulatory Reporting Industrial Placement - September 2026

Sr. Drug Safety Specialist

Senior Manager – ESG and Sustainability Regulatory Legal

Expert Consultant – Healthcare | Safety, Risk & Regulatory

Medical Affairs Advisor

Clinical Data & Device Specialist

Consultant

Director - Regulatory Affairs Lifecycle Management Non-Medicines

Medical Information Specialist - Spanish & English speaking

Director - Regulatory Affairs Lifecycle Management Medicines

Regulatory Market Access Lead

Medical Information Specialist - German & English speaking

Director, Government Affairs and Advocacy - Europe and International

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