Operations representative Work, Jobs in Dummer, Ham (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
6d
Customer Service Representative
Curium Pharma —Portsmouth
- Microsoft Word
- Analysis skills
- Organisational skills
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TP-Link UK Ltd —Thatcham
- From £27,000 a year
- Full-time
- Microsoft Word
- Microsoft Outlook
- Computer literacy
- Free parking
- Sick pay
Quick apply
Business Development Lead Defence
Saab —Fareham
- Hybrid work
- CRM software
- Sales
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5d
Safety, Health and Compliance Officer
Southampton City Council —Southampton
- £37,280 - £40,778 a year
- Full-time
- Communication skills
- Employee assistance programme
- Employee discount
19h
Security Technician
Fujitsu —Bracknell
- Communication skills
12d
HSE Manager
Prysmian Group —Bishopstoke
- Engineering
- English
- Continuous improvement
- Free parking
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Business Development Manager
Sovos Compliance —Farnborough
- CRM software
- English
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Quick apply
6d
Opportunities at TCS - Satellite Communications Technician
Serco Plc —Bordon
- Call to connect
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Site Technician
Saab —Andover
- Maintenance
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Quality Control Inspector
Saab —Fareham
- Computer literacy
- English
- Quality control
Business Development Representative
Sovos Compliance —Farnborough
- CRM software
- Business development
- Bachelor's degree
Quick apply
4d
Senior Manager, UK – Defense Systems & Ecosystem Development
Analog Devices —Newbury
- Full-time
- Travel
- Leadership
- Up to 25% travel
Cleaning Supervisor Ref 320/PC
Birkin Cleaning Services Limited —Wokingham
- £13.71 an hour
- Part-time
- Management
- Supervising experience
- In-person
Quick apply
5d
Contract Management Specialist
Prysmian Group —Bishopstoke
- Organisational skills
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BOM Cost Controller
Alexander Dennis —Farnborough
- Full-time
- Hybrid work
- Engineering
- Analysis skills
- Analytics
Quick apply
Framework Manager - Navy Future Dredging Capability (NFDC)
Boskalis —Fareham
- Part-time
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Java Engineer
InfoSum —Basingstoke
- Hybrid work
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Quick apply
Manufacturing & Process Quality Engineer
Capgemini Sogeti —Southampton
- Hybrid work
Personal Assistant to ADS Membership Director and Head of SME Engagement
ADS Group Ltd —Farnborough
- Full-time
- CRM software
- Microsoft Outlook
- Databases
6d

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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
6 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

operations representative jobs in dummer, ham

Medical Device Regulatory Affairs Specialist

Customer Service Representative

RMA Processor

Business Development Lead Defence

Safety, Health and Compliance Officer

Security Technician

HSE Manager

Business Development Manager

Opportunities at TCS - Satellite Communications Technician

Site Technician

Quality Control Inspector

Business Development Representative

Senior Manager, UK – Defense Systems & Ecosystem Development

Cleaning Supervisor Ref 320/PC

Contract Management Specialist

BOM Cost Controller

Framework Manager - Navy Future Dredging Capability (NFDC)

Java Engineer

Manufacturing & Process Quality Engineer

Personal Assistant to ADS Membership Director and Head of SME Engagement

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