Senior Regulatory Affairs Lead - MedTech & IVDs (EU/UK)

Website; Cambridge; On-site; GBP 70,000 - 90,000; Full time

Benefits offered by this job

25 days annual leave

Pension contribution

Competitive Salary

Employee wellbeing initiatives

Job summary

TOGL(Holdings)Limited is a diagnostics company focused on gastrointestinal diseases. We seek a proactive Regulatory Manager to lead development through EU MDR/IVDR pathways, including SaMD and genomic diagnostics, across EU, UK and international markets.

The role involves creating Technical Documentation, regulatory strategy, and LIFE-CYCLE management with cross-functional teams, ensuring compliance from product concept to post-market.

Qualifications

• Significant Regulatory Affairs experience in medical devices/IVD.
• Strong knowledge of EU MDR and IVDR requirements.
• Experience with SaMD and software validation.
• Experience preparing Technical Documentation and CERs/PERs/BERs.
• Familiarity with Notified Bodies and regulatory submissions.

Responsibilities

• Lead Regulatory Affairs for medical devices and IVDs, including SaMD and genomic diagnostics.
• Develop, maintain and update Technical Documentation per EU MDR/IVDR.
• Support regulatory strategies for product development and lifecycle management.
• Prepare and maintain regulatory documentation (Technical Files, CERs, PERs, BERs).
• Provide regulatory input throughout product development and ensure design controls.
• Lead regulatory activities related to analytical and clinical performance and software validation.
• Support Post-Market Surveillance, PMS and regulatory compliance.
• Coordinate with R&D, Software, QA to embed regulatory requirements.
• Assist with regulatory submissions and Notified Body interactions, and market access.

Skills

Regulatory Affairs

Medical Devices

IVD Knowledge

SaMD

IEC 62304

ISO 13485

Regulatory Strategy

Education

Biomedical Science degree

Life Sciences degree

Job description

TOGL(Holdings)Limited is a diagnostics company focused on gastrointestinal diseases. We seek a proactive Regulatory Manager to lead development through EU MDR/IVDR pathways, including SaMD and genomic diagnostics, across EU, UK and international markets.

The role involves creating Technical Documentation, regulatory strategy, and LIFE-CYCLE management with cross-functional teams, ensuring compliance from product concept to post-market.