Senior Regulatory Affairs Specialist
Location: Warrington (Remote/Hybrid)
Rate: £50-£60 per hour
Working Hours: Mon-Fri, flexible between 09:00-18:00
We are looking for an experienced Senior Regulatory Affairs Specialist to join the Life Sciences Group (LSG) EMEA Regulatory Affairs team. This role will focus on managing and leading IVD and Medical Device registrations across EMEA, ensuring compliance while supporting business growth and market expansion.
You will work in a highly collaborative, international environment, partnering across functions to deliver effective regulatory strategies and maintain competitive advantage.
Key Responsibilities
Lead and manage national product and establishment registrations across EMEA
Develop and execute regional regulatory strategies aligned with global objectives
Act as key contact for regulatory authorities and distributors
Oversee submission activities, track progress, and ensure timely approvals
Maintain regulatory databases and ensure data accuracy and completeness
Monitor regulatory changes and provide impact assessments and strategic guidance
Support post-market vigilance activities in collaboration with relevant teams
Guide and oversee distributor-led submissions to ensure compliance
Drive process improvements and enhance regulatory workflows
Deliver training and regulatory guidance to internal stakeholders
Participate in regulatory intelligence activities across the organisationMinimum Qualifications
8-10+ years of Regulatory Affairs experience in IVD or Medical Devices (EMEA region)
Strong knowledge of ISO 13485 and European IVD/MD regulations
Proven experience with national registrations across Europe, Middle East, and Africa
Experience leading regulatory strategy on cross-functional projects
Strong track record of interacting with regulatory authorities and external partners
Solid understanding of:
IVD reagent chemistry
Laboratory automation
Software components in medical devicesKey Skills & Competencies
Strong leadership and communication skills
Ability to work autonomously in a matrix organisation
Solution-oriented with strong regulatory judgement
Comfortable working under pressure and managing ambiguity
Continuous improvement mindset with process optimisation experience
Effective cross-regional collaboration (US, Europe, Asia)
Willingness to travel (10-15%)
Strong IT and systems proficiencyWork Environment & Benefits
Remote or hybrid working model
International, cross-functional team exposure
Laptop and accessories provided
Dynamic and fast-paced regulatory environment