Lead Quality & Regulatory Specialist
other jobs Broadgate Search Ltd
Added before 4 hours
- England,London,City of London
- Full Time, Permanent
- £75,000 - £110,000 per annum
Job Description:
Lead Quality & Regulatory Specialist
Location: 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.
Location: 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.
Job number 3218402
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Company Details:
Broadgate Search Ltd
Broadgate Search is a niche supplier of Mid-Senior Risk Management, Regulatory Compliance and Audit professionals to clients across Financial Services...