Affairs specialist Work, Jobs in Chilton, Oxf (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
Senior Regulatory Affairs Specialist
Kenvue —Reading
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
- Annual leave
Senior Specialist Regulatory Affairs
Abbott Laboratories —Witney
- Full-time
- Bachelor's degree
- Mentoring
- Communication skills
Paralegal
EMG Solicitors —Reading
- Full-time
- Business development
- Organisational skills
- Time management
- Annual leave
- Employee assistance programme
11d
QA Specialist W&D
Medline Europe —Bicester
- Microsoft Word
- Bachelor's degree
- Continuous improvement
- Employee assistance programme
- Life insurance
Quick apply
13d
Incident Comms Specialist
Thames Water Utilites —Reading
- £49,000 - £55,000 a year
- Full-time
- Continuous improvement
- Leadership
- Annual leave
11d
Researcher in Reproductive Demography
University of Oxford —Oxford
- £39,424 - £47,779 a year
- Full-time
- Doctoral degree
- Research
- Communication skills
QA Specialist W&D
ASID BONZ GmbH —Bicester
- Microsoft Word
- Bachelor's degree
- Continuous improvement
- Employee assistance programme
- Life insurance
13d
BUH UKI Nordics Advanced Surgery
Baxter —Newbury
- £120,000 - £165,000 a year
- Management
- Master's degree
- Bachelor's degree
Practice Area Lead: Medical Affairs Communications
IQVIA —Reading
- Full-time
- Hybrid work
- Business development
- Training & development
- Leadership
Associate Director - Tax
Grant Thornton UK LLP —Reading
- Full-time
- Business development
- Tax experience
- Employee discount
Solicitor - Court of Protection
Hugh James —Swindon
- Full-time
- Hybrid work
- Business development
- Analysis skills
- Communication skills
- Employee assistance programme
- Employee discount

I want to receive the latest job alerts for affairs specialist in chilton, oxf

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Medical Device Regulatory Affairs Specialist

Clinica Engineering Medical Solutions Ltd
Reading

Quick apply

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

Quick apply

Refine Your Search

affairs specialist jobs in chilton, oxf

Medical Device Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Senior Specialist Regulatory Affairs

Paralegal

QA Specialist W&D

Incident Comms Specialist

Researcher in Reproductive Demography

QA Specialist W&D

BUH UKI Nordics Advanced Surgery

Practice Area Lead: Medical Affairs Communications

Associate Director - Tax

Solicitor - Court of Protection

I want to receive the latest job alerts for affairs specialist in chilton, oxf

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected