Pharmaceutical consultant Work, Jobs in Bledlow, Bkm (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
Sustainability Manager
CSafe Global —Long Crendon
- Full-time
- Microsoft Word
- Bachelor's degree
- Continuous improvement
Quick apply
Events & Digital Marketing Coordinator
Oakley Food Projects —Wokingham
- £22,450 - £25,650 a year
- Part-time
- Social media management
- Organisational skills
- In-person
- Free parking
- Profit sharing
Quick apply
Engineering Science Consultant - Life Sciences (Graduate)
Capgemini —Abingdon
- Hybrid work
- Doctoral degree
- Engineering
- Master's degree
Manager, Implementation Services
Loftware —Reading
- £85,000 - £110,000 a year
- Hybrid work
- Master's degree
- Bachelor's degree
- Continuous improvement
Quick apply
2d
FSP Solutions Consultant
Fortrea —Maidenhead
- Full-time
- Salesforce
- Business development
- Presentation skills
Senior Benefits Risk Management Lead
Bayer —Reading
- £110,000 - £130,000 a year
- Full-time
- Hybrid work
- English
- Databases
- Continuous improvement
- Annual leave
- Employee discount
Associate Principal / Principal, Clinical Outcome Assessment (COA) Strategy Consulting
IQVIA —Reading
- Full-time
- Hybrid work
- Doctoral degree
- Master's degree
- Business development
Principal Scientist PK/PD
UCB —Slough
- Doctoral degree
- Leadership
Project Manager
Laing O'Rourke —Oxford
- Engineering
- Annual leave
- Employee assistance programme
Heart Failure Specialist Pharmacist
IQVIA —Reading
- Part-time
- Hybrid work
- Research
- Master's degree
- Communication skills
- Employee discount
- Gym membership
Head, PV and Regulatory QA
CSL Seqirus —Maidenhead
- Full-time
- Bachelor's degree
- Continuous improvement
- Quality control
Senior Project Manager
Laing O'Rourke —Oxford
- Engineering
- Laboratory experience
- Continuous improvement
- Annual leave
- Employee assistance programme
11d
Specialist Cancer Pharmacist
Oxford University Hospitals NHS Foundation Trust —Oxford
- £49,387 - £56,515 a year
- Weekend availability
- Doctoral degree
- Quality control
- Patient care
10d
VP, Sales, EMEA
IQVIA —Reading
- Full-time
- Hybrid work
- Master's degree
- Business development
- Analysis skills
Senior Designer
Walker & Sloan —Reading
- £60,000 - £80,000 a year
- HVAC
- Leadership
- Communication skills
- Profit sharing
10d
Lead Pharmacist
ICON UK —Reading
- £75,000 a year
- Full-time
- Bachelor's degree
- Continuous improvement
- Patient care
- Annual leave
- Employee assistance programme
Quick apply
10d
Bulb - Preconstruction Manager
Unispace Life Sciences —Maidenhead
- No degree
- Contracts
- Construction experience
Quick apply
Senior Manager, Packaging Engineering
Moderna, Inc. —Oxford
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
- Annual leave
Bank Pharmacist
Spire Healthcare —Reading
- Part-time
- Patient care
- Hospital experience
- Annual leave

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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

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

pharmaceutical consultant jobs in bledlow, bkm

Medical Device Regulatory Affairs Specialist

Sustainability Manager

Events & Digital Marketing Coordinator

Engineering Science Consultant - Life Sciences (Graduate)

Manager, Implementation Services

FSP Solutions Consultant

Senior Benefits Risk Management Lead

Associate Principal / Principal, Clinical Outcome Assessment (COA) Strategy Consulting

Principal Scientist PK/PD

Project Manager

Heart Failure Specialist Pharmacist

Head, PV and Regulatory QA

Senior Project Manager

Specialist Cancer Pharmacist

VP, Sales, EMEA

Senior Designer

Lead Pharmacist

Bulb - Preconstruction Manager

Senior Manager, Packaging Engineering

Bank Pharmacist

I want to receive the latest job alerts for pharmaceutical consultant in bledlow, bkm

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