Lead Quality & Regulatory Specialist

Lead Quality & Regulatory SpecialistLocation: London A leading innovative digital health company is seeking a Lead Quality & Regulatory Specialist to support the VP of Regulatory in developing and executing quality and regulatory strategies for Software as a Medical Device.This hands-on role will be instrumental in building and maintaining regulatory compliance frameworks across the US, UK, and EU, helping prepare products for certification and market clearance.Role Responsibilities:

• Support the development and execution of global regulatory and quality strategies.
• Prepare and review documentation for FDA, EU MDR, and UK MHRA submissions.
• Define device intended use, risk classification, and regulatory pathways for SaMD.
• Assist in the implementation and maintenance of the Quality Management System aligned with ISO 13485, 21 CFR Part 820, and EU MDR.
• Draft and maintain SOPs, work instructions, and templates.
• Contribute to the creation and management of technical documentation and medical device files.
• Support internal and external audit readiness, including training and CAPA management.
• Partner with cross-functional teams to ensure regulatory requirements are integrated into product development.

Requirements:

• 6+ years' experience in Regulatory Affairs and Quality Assurance within medical devices, digital health, or SaMD.
• Proven experience with FDA and/or EU MDR submissions (Class II or higher).
• Strong understanding of regulatory frameworks and standards, including ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820.
• Hands-on experience supporting QMS implementation and audit preparation.

Desirable: Experience setting up QMS from scratch, using regulatory tools (e.g., MasterControl, Greenlight Guru), or acting as PRRC/Deputy PRRC.