Remote-Ready Quality & Regulatory Lead for SaMD

Flo Health; City of Westminster; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading health & fitness application in the UK is seeking a highly skilled Lead Quality & Regulatory Specialist. You will support regulatory clearance and certification processes for Software as a Medical Device, collaborating across teams to align product development with regulatory requirements. The ideal candidate should have over 6 years of experience in regulatory affairs, robust documentation skills, and the ability to work in fast-paced environments. This role offers competitive salary and benefits focused on women's health.

Benefits

Competitive salary and annual reviews

Paid holiday, sick leave, and female health leave

Enhanced parental leave and pay

Flexible office + home working

5-week fully paid sabbatical at 5-year Floversary

Qualifications

• 6+ years of experience in regulatory affairs, ideally with medical devices or SaMD.
• Proven track record of successful FDA and/or EU regulatory submissions.
• In-depth knowledge of regulations such as EU MDR and ISO 13485.
• Experience in fast-paced, cross-functional environments.

Responsibilities

• Collaborate with teams to execute regulatory strategy.
• Prepare regulatory documentation for submissions.
• Support the development of Flo's quality management system.
• Conduct mock audits and assist with regulatory compliance.

Skills

Regulatory affairs expertise

Strong documentation skills

Excellent communication

Project coordination

Education

A relevant degree in a regulatory, scientific, engineering, legal, or medical field

Tools

MasterControl

Greenlight Guru

Job description

A leading health & fitness application in the UK is seeking a highly skilled Lead Quality & Regulatory Specialist. You will support regulatory clearance and certification processes for Software as a Medical Device, collaborating across teams to align product development with regulatory requirements. The ideal candidate should have over 6 years of experience in regulatory affairs, robust documentation skills, and the ability to work in fast-paced environments. This role offers competitive salary and benefits focused on women's health.