Regulatory reporting 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
3d
Regulatory Affairs Executive
Sandoz —Bracknell
- Full-time
- Project management
- Annual leave
Regulatory Compliance Lead
Thames Water Utilites —Reading
- Up to £58,000 a year
- Full-time
- Microsoft Office
- Communication skills
6d
VodafoneThree - Health, Safety and Environmental Specialist
Vodafone —Newbury
- Full-time
- Remote
- Computer literacy
- Travel
- Computer skills
- Employee discount
2d
Operations & Compliance Coordinator
ACE Kids —Sandhurst
- £28,000 - £32,000 a year
- Full-time
- Hybrid work
- Microsoft Outlook
- Administrative experience
- Recruiting
- Free parking
- Work from home
Quick apply
2d
Compliance Administrator
Active Care Group —Thame
- £28 - £30 an hour
- Full-time
- Microsoft Word
- Microsoft Outlook
- Databases
Quick apply
Clinical Research Coordinator
University of Oxford —Oxford
- £32,108 - £37,338 a year
- Full-time
- University
- Communication skills
6d
HR Administrator
Practice Plus Group IUC —Reading
- £30,985.98 a year
- Customer service
- Microsoft Office
- Administrative experience
9d
Compliance Service Delivery Lead
Lifetime Legal Ltd —Wokingham
- Up to £35,000 a year
- Full-time
- Continuous improvement
- Mentoring
- Organisational skills
Quick apply
11d
Stability Microbiologist (12 months Fixed Term)
Thermo Fisher Scientific —Basingstoke
- Full-time
- Organisational skills
- Communication skills
Research Support Administrator
Buckinghamshire New University —High Wycombe
- £26,093 - £28,778 a year
- Hybrid work
- Customer service
- University
- Organisational skills
- Employee discount
HSSE Specialist
Exolum —Aldermaston
- £55,000 - £60,000 a year
- Analysis skills
2d
Associate Principal/Principal Qualitative Research, Patient Centered Solutions
IQVIA —Reading
- Full-time
- Hybrid work
- Doctoral degree
- English
- Master's degree
Enhanced Due diligence Service Delivery Lead
Lifetime Legal Ltd —Wokingham
- Up to £36,000 a year
- Full-time
- Customer service
- Continuous improvement
- Organisational skills
Quick apply
11d
VodafoneThree - Network Test Environment Specialist Test Environment Specialist
Vodafone —Reading
- Full-time
- Hybrid work
- Data analysis skills
- Employee discount
1d
Quality Assurance and Operational Risk Specialist
Castle Trust Bank —Basingstoke
- Full-time
- Hybrid work
- Communication skills
- Employee assistance programme
- Employee discount
Quick apply
Data Operations Analyst
LRG —Camberley
- Remote
- SQL
- Analysis skills
- Travel
Quick apply
Safety Support Coordinator
QinetiQ —Farnborough
- £42,300 - £47,000 a year
- Full-time
- In-person
- Communication skills
- Free parking
- Store discount
12d
QA Specialist
MedPharm —Guildford
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
Quick apply
SVP Regulatory Affairs & Quality Assurance
PrecisionLife Ltd —Oxford
- £85,000 - £105,000 a year
- Full-time
- Hybrid work
- Doctoral degree
- Computer Science
- Engineering
- Free parking
- Annual leave
Quick apply
9d

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regulatory reporting jobs near reading, 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
3 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 reporting jobs in reading, eng

Medical Device Regulatory Affairs Specialist

Regulatory Affairs Executive

Regulatory Compliance Lead

VodafoneThree - Health, Safety and Environmental Specialist

Operations & Compliance Coordinator

Compliance Administrator

Clinical Research Coordinator

HR Administrator

Compliance Service Delivery Lead

Stability Microbiologist (12 months Fixed Term)

Research Support Administrator

HSSE Specialist

Associate Principal/Principal Qualitative Research, Patient Centered Solutions

Enhanced Due diligence Service Delivery Lead

VodafoneThree - Network Test Environment Specialist Test Environment Specialist

Quality Assurance and Operational Risk Specialist

Data Operations Analyst

Safety Support Coordinator

QA Specialist

SVP Regulatory Affairs & Quality Assurance

I want to receive the latest job alerts for regulatory reporting in reading, eng

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