Senior Regulatory Affairs Specialist - Hybrid (Warr
Warrington
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 organisation
Minimum 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 devices
Key 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 proficiency
Work Environment & Benefits
- Remote or hybrid working model
- International, cross-functional team exposure
- Laptop and accessories provided
- Dynamic and fast-paced regulatory environment
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Recruiter: Manpower UK
Salary: £50 to £60 Per Hour
Reference: BBBH435041