Regulatory Affairs Associate – Medical Devices (12-Month FTC)

L-ev8 Recruitment Ltd; Northwich; Hybrid; GBP 38,000 - 45,000; Full time

Job summary

A leading recruitment agency is looking for a Regulatory Affairs Associate for a 12-month FTC based in Cheshire. The role involves managing regulatory compliance for medical devices across global markets, including the creation and maintenance of regulatory documentation and submissions. The ideal candidate will have a degree in a Life Science discipline and experience in a regulated environment. A strong understanding of EU and FDA regulations is essential, and the position supports hybrid working arrangements.

Qualifications

• Experience working within a regulated medical device environment.
• Strong understanding of EU MDR and FDA Quality System Regulation (QSR).
• Experience maintaining Technical Files and supporting regulatory submissions.

Responsibilities

• Create and maintain Regulatory Technical Documentation to ensure compliance.
• Manage regulatory submissions supporting changes to existing products.
• Collaborate with Quality, R&D, Engineering, and Clinical teams.

Skills

Regulatory submissions

Regulatory compliance

Documentation management

Collaboration with teams

Education

Degree in a Life Science or related discipline

Tools

ISO 13485

Job description

A leading recruitment agency is looking for a Regulatory Affairs Associate for a 12-month FTC based in Cheshire. The role involves managing regulatory compliance for medical devices across global markets, including the creation and maintenance of regulatory documentation and submissions. The ideal candidate will have a degree in a Life Science discipline and experience in a regulated environment. A strong understanding of EU and FDA regulations is essential, and the position supports hybrid working arrangements.