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Medical Device Documentation Lead - Job Opportunity at MSI Group Ltd

Slough, United Kingdom
Contract
Senior
Posted: April 14, 2025
Hybrid
GBP 146,000-166,400 per year

Key Responsibilities

Lead authorship and management of technical documentation for Design History File and regulatory submissions
Drive cross-functional collaboration with quality, regulatory, safety and technical teams
Oversee protocol and scientific report development
Manage documentation partnerships with strategic vendors
Ensure regulatory compliance across EU MDR, 21 CFR, ISO 13485, and GMP standards
Direct data integrity reviews and CMC section preparations

Requirements

Education

Master's degree in relevant scientific discipline

Experience

8+ years in medical devices or drug-device combination products

Required Skills

Technical documentation expertise Device regulations knowledge English writing and communication Project management Cross-functional team leadership Understanding of pharmaceutical standards French language (Preferred)
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Sauge AI Market Intelligence

Industry Trends

Increasing complexity in drug-device combination products is driving higher demand for documentation specialists with cross-domain expertise Regulatory framework evolution, particularly EU MDR implementation, is creating sustained demand for technical documentation experts Growing emphasis on digital documentation systems and data integrity is reshaping documentation roles

Salary Evaluation

The offered compensation of £70-80 per hour (£146,000-166,400 annually) aligns with market rates for senior documentation leads in the pharmaceutical sector, particularly given the specialized drug-device combination product focus

Role Significance

Typically leads a documentation team of 3-5 specialists while coordinating with 15-20 cross-functional stakeholders
Senior strategic position with direct impact on product approval pathways and regulatory compliance

Key Projects

Design History File compilation for novel drug-device combination products Technical documentation strategy development Regulatory submission preparation Quality management system documentation

Success Factors

Deep understanding of both medical device and pharmaceutical regulatory landscapes Strong stakeholder management across multiple geographic locations Ability to translate complex technical information into clear documentation Experience with electronic document management systems

Market Demand

High demand with limited talent pool due to specialized expertise requirements in both medical device and pharmaceutical regulations

Important Skills

Critical Skills

Technical documentation expertise - Essential for ensuring regulatory compliance and product approval Regulatory knowledge - Critical for navigating complex medical device and pharmaceutical requirements Cross-functional leadership - Vital for coordinating multiple stakeholder inputs and ensuring documentation quality

Beneficial Skills

French language skills - Advantageous for European market operations Experience with electronic documentation systems - Important for modern documentation management Understanding of data integrity principles - Increasingly important in regulatory submissions

Unique Aspects

Rare opportunity combining both medical device and pharmaceutical expertise
Multi-site flexibility across major European pharmaceutical hubs
Strategic importance in product development and regulatory approval processes

Career Growth

2-3 years in role typical before advancement, dependent on project success and regulatory expertise development

Potential Next Roles

Head of Technical Documentation Regulatory Affairs Director Quality Systems Manager Medical Device Program Manager

Company Overview

MSI Group Ltd

MSI Group Ltd operates as a specialized healthcare recruitment firm, connecting pharmaceutical and medical device companies with highly skilled professionals

Mid-tier recruitment specialist with strong presence in the European pharmaceutical and medical device sectors
Strategic position offering placements across multiple European locations including UK, Belgium, and Switzerland
Professional consulting environment with emphasis on expertise and client service
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