Regulatory affairs Work, Jobs in Maidenhead, 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
2d
Assistant - Regulatory Affairs Lifecycle Management Medicines
Perrigo —London
- Hybrid work
- Continuous improvement
- Organisational skills
- In-person
9d
Medical Affairs Coordinator
Servier —Slough
- Microsoft Office
- Databases
- Administrative experience
5d
Northern Europe Regulatory Affairs Director
Kenvue —Reading
- Hybrid work
- Management
- English
- Analysis skills
Sr. Principal Scientist, Advisor, Sr. Advisor of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices-EMEA
Eli Lilly —Bracknell
- Full-time
- Doctoral degree
- English
- Master's degree
Assistant Professional Regulatory Affairs - Lifecycle Management - Regulatory Operations
Perrigo —London
- Hybrid work
- Continuous improvement
- Quality control
- Organisational skills
9d
Scientific Editor
WebMD —London
- Full-time
- Microsoft Office
- Bachelor's degree
- Quality control
Quick apply
Quality Assurance & Regulatory Affairs Executive - Maternity Cover
TensCare Ltd —Epsom
- £35,000 - £42,500 a year
- Temporary
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Team management
- Profit sharing
- Work from home
Quick apply
3d
Director, Regulatory Affairs, Europe
GE HEALTHCARE —Chalfont Saint Giles
- Engineering
- Master's degree
- Bachelor's degree
Medical Science Liaison
Merz Aesthetics GmbH —Hemel Hempstead
- CRM software
- Nursing
- Microsoft Office
Quick apply
Head of Global Labelling
CSL Seqirus —Maidenhead
- Full-time
- Management
- Continuous improvement
- Leadership
Vice President, Regulatory Affairs – ELMAC
Amgen —Uxbridge
- Doctoral degree
- Master's degree
- Bachelor's degree
Regulatory Compliance Supervisor (m/f/x)
3M —Bracknell
- Full-time
- Engineering
- Research
- Master's degree
- Flexible schedule
Director - Regulatory Affairs Lifecycle Management Non-Medicines
Perrigo —London
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Team management
2d
Director of Public Affairs, UK
Abbott Laboratories —Maidenhead
- Full-time
- Bachelor's degree
- Budgeting
- Communication skills
Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology
Recordati —Hemel Hempstead
- Full-time
- Hybrid work
- English
- Quality control
- Travel
12d
Manager - Regulatory Affairs Lifecycle Management - Medicines
Perrigo —London
- Hybrid work
- Marketing
- English
- Continuous improvement
9d
EU Labeling, Advertising and Promotion Scientist (UK)
UCB —Slough
- Communication skills
Associate Director, Global Medical Affairs (2-year contract)
BioNTech AG —London
- Full-time
- Doctoral degree
- Project management
- Travel
PR Account Executive, Financial Services (entry level role)
MHP Group —London
- Hybrid work
- Writing skills
- Employee assistance programme
- Employee discount
9d

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regulatory affairs jobs near maidenhead, 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
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 affairs jobs in maidenhead, eng

Medical Device Regulatory Affairs Specialist

Assistant - Regulatory Affairs Lifecycle Management Medicines

Medical Affairs Coordinator

Northern Europe Regulatory Affairs Director

Sr. Principal Scientist, Advisor, Sr. Advisor of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices-EMEA

Assistant Professional Regulatory Affairs - Lifecycle Management - Regulatory Operations

Scientific Editor

Quality Assurance & Regulatory Affairs Executive - Maternity Cover

Director, Regulatory Affairs, Europe

Medical Science Liaison

Head of Global Labelling

Vice President, Regulatory Affairs – ELMAC

Regulatory Compliance Supervisor (m/f/x)

Director - Regulatory Affairs Lifecycle Management Non-Medicines

Director of Public Affairs, UK

Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology

Manager - Regulatory Affairs Lifecycle Management - Medicines

EU Labeling, Advertising and Promotion Scientist (UK)

Associate Director, Global Medical Affairs (2-year contract)

PR Account Executive, Financial Services (entry level role)

I want to receive the latest job alerts for regulatory affairs in maidenhead, eng

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