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Regulatory Affairs Program Manager - Job Opportunity at Cepheid

Amersham, United Kingdom
Full-time
Senior
Posted: April 18, 2025
Remote
GBP 75,000 - 95,000 annually based on seniority and UK market conditions for senior regulatory affairs roles

Benefits

Comprehensive healthcare program
Flexible remote work arrangement
Annual leave
Competitive benefits package through Danaher
Career development opportunities
Global work environment

Key Responsibilities

Lead IVDR sustainment activities to maintain regulatory compliance
Coordinate cross-functional teams for technical documentation management
Serve as IVDR Subject Matter Expert for regulatory strategy
Develop and implement regulatory compliance strategies
Provide mentorship and regulatory training to team members
Manage post-launch technical documentation for CE IVDR portfolio

Requirements

Education

Bachelor's degree with 8+ years experience or Master's degree with 6+ years experience

Experience

8+ years with Bachelor's or 6+ years with Master's, 3+ years EU IVDR/MDR experience, 2+ years project management

Required Skills

IVDR/MDR regulatory expertise Technical documentation management Project management Cross-functional team leadership Problem-solving Strategic planning Global team collaboration
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Sauge AI Market Intelligence

Industry Trends

Increasing regulatory complexity in IVD sector due to IVDR implementation is driving high demand for specialized regulatory professionals Shift towards remote regulatory operations is becoming standard in global medical device companies Growing emphasis on post-market surveillance and continuous compliance maintenance in EU markets

Role Significance

Likely leads or coordinates with 5-8 regulatory specialists across global locations
Senior strategic position with significant influence on company's EU market access and compliance strategy

Key Projects

IVDR technical documentation maintenance programs Post-market surveillance system implementation Regulatory compliance strategy development Cross-functional team coordination for sustained compliance

Success Factors

Deep understanding of EU IVDR requirements and implementation strategies Ability to navigate complex regulatory landscapes while maintaining business objectives Strong stakeholder management across global teams Experience in change management and process improvement

Market Demand

Very high demand due to ongoing IVDR transition period and limited pool of experienced IVDR specialists

Important Skills

Critical Skills

IVDR/MDR regulatory knowledge is essential due to ongoing regulatory changes in EU Program management capabilities are crucial for coordinating complex compliance activities Strategic thinking for long-term regulatory planning

Beneficial Skills

Quality management system experience Change management expertise Understanding of global regulatory frameworks beyond EU

Unique Aspects

Role combines technical regulatory expertise with program management in rapidly evolving regulatory landscape
Opportunity to shape regulatory strategy for leading diagnostics company
Remote work flexibility while maintaining global impact

Career Growth

2-4 years in role before advancement, depending on business growth and regulatory landscape evolution

Potential Next Roles

Global Regulatory Affairs Director Head of Regulatory Affairs Regulatory Strategy Lead Quality and Regulatory Excellence Leader

Company Overview

Cepheid

Cepheid, as part of Danaher, is a leading molecular diagnostics company focused on innovative testing solutions

Strong market position in molecular diagnostics with significant growth potential due to increasing demand for rapid diagnostic solutions
Major player in European IVD market with significant investment in IVDR compliance
Innovation-driven environment with strong focus on professional development and global collaboration
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  • Salary estimates and market demand analysis
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  • Critical success factors and key skills
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