Regulatory specialist Work, Jobs in Reading, 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
Regulatory Officer - Combined Packaging Regime - 36042
Environment Agency —Reading
- £34,320 a year
- Part-time
- Microsoft Office
- Presentation skills
- Travel
- Flexible schedule
12d
VodafoneThree - Health, Safety and Environmental Specialist
Vodafone —Newbury
- Full-time
- Remote
- Computer literacy
- Travel
- Computer skills
- Employee discount
18h
Quality Assurance Specialist
UK Research and Innovation (UKRI) —Didcot
- £46,444 a year
- Full-time
- Bachelor's degree
- Travel
- Communication skills
- Employee discount
- Flexible schedule
15h
Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Bachelor's degree
- Annual leave
QA Specialist
MedPharm —Guildford
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
Quick apply
Scientist, Analytical Development
Bristol-Myers Squibb —North Moreton
- Full-time
- Hybrid work
- Doctoral degree
- Master's degree
- Travel
1d
Clinical Application Specialist
Clinica Engineering Medical Solutions Ltd —Reading
- £2,700 - £3,200 a month
- Full-time
- Nursing
- Travel
- IT
Quick apply
Site Activation Specialist
IQVIA —Reading
- Full-time
- Remote
- Travel
- Work from home
Junior Technical Specialist (Microbiology & Immunology)
University of Oxford —Oxford
- £35,681 - £45,212 a year
- Full-time
- Laboratory experience
- Communication skills
19h
Quality Assurance and Operational Risk Specialist
Castle Trust Bank —Basingstoke
- Full-time
- Hybrid work
- Communication skills
- Employee assistance programme
- Employee discount
Quick apply
Technical Specialist (Microbiology & Immunology)
University of Oxford —Oxford
- £39,424 - £51,983 a year
- Full-time
- Laboratory experience
- Mentoring
- Training & development
19h
eDiscovery Specialist
Vodafone —Newbury
- Full-time
- Computer Science
- Analysis skills
- Quality control
- Annual leave
7d
Trade Compliance Senior Specialist
Vodafone —Newbury
- Full-time
- Analysis skills
- Communication skills
QA Specialist - NPI
GE HEALTHCARE —Chalfont Saint Giles
- £56,000 - £77,000 a year
- Bachelor's degree
- Travel
- Contracts
Functional Skills Lead
Berkshire Healthcare NHS Foundation Trust —Reading
- £39,959 - £48,117 a year
- Part-time
- Maths
- Education
- Continuous improvement
- Free parking
- Annual leave
16h
Compliance Administrator
Active Care Group —Thame
- £28 - £30 an hour
- Full-time
- Microsoft Outlook
- Administrative experience
- Organisational skills
Quick apply
Pharmacy Team Lead
Montu UK —Wokingham
- £35,000 - £45,000 a year
- Weekend availability
- Computer literacy
- Continuous improvement
- Mentoring
- Free parking
Quick apply
4d
Environmental Consultant
SOCOTEC UK & Ireland —Reading
- Full-time
- Hybrid work
- Driving
- IT
- Communication skills
- Employee assistance programme
- Employee discount
Quick apply
Revenue Enablement Specialist (EMEA)
Geotab —Reading
- Hybrid work
- Bilingual
- Sales
- Salesforce

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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

regulatory specialist jobs in reading, brk

Medical Device Regulatory Affairs Specialist

Regulatory Officer - Combined Packaging Regime - 36042

VodafoneThree - Health, Safety and Environmental Specialist

Quality Assurance Specialist

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

QA Specialist

Scientist, Analytical Development

Clinical Application Specialist

Site Activation Specialist

Junior Technical Specialist (Microbiology & Immunology)

Quality Assurance and Operational Risk Specialist

Technical Specialist (Microbiology & Immunology)

eDiscovery Specialist

Trade Compliance Senior Specialist

QA Specialist - NPI

Functional Skills Lead

Compliance Administrator

Pharmacy Team Lead

Environmental Consultant

Revenue Enablement Specialist (EMEA)

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

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