Medical Devices Compliance Lead (SaMD)

TL;DR

Medical Devices Compliance Lead (SaMD): Leading the regulatory strategy and implementation of medical device standards for a healthcare communication platform with an accent on SaMD, AIaMD, and UK MDR. Focus on owning technical files, implementing ISO 13485 QMS, and ensuring audit readiness for MHRA submissions.

Location: Hybrid in London (Shoreditch), UK (3 days a week in office)

Company

hirify.global is a healthcare communication platform used by 98% of GP practices in the NHS to connect patients and clinicians through a unified digital toolkit.

What you will do

• Own the structure, development, and maintenance of technical files (STED) ensuring they are submission-ready for Approved Bodies and MHRA.
• Lead the design and implementation of a Quality Management System (QMS) aligned with ISO 13485.
• Translate UK MDR and EU MDR requirements into practical guidance for product development teams.
• Implement risk management processes in accordance with ISO 14971.
• Coordinate Approved Body interactions and ensure continuous audit readiness.
• Establish post-market surveillance and lifecycle processes to maintain regulatory compliance.

Requirements

• Proven experience with Class I-III medical devices.
• Expertise in Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD).
• Deep knowledge of UK MDR and EU MDR regulatory frameworks.
• Experience implementing ISO 13485 and ISO 14971 standards.
• Must be based in the UK to support the hybrid office model in London.

Culture & Benefits

• Office-first culture in a dog-friendly Shoreditch office with free healthy breakfasts, snacks, and lunches provided by an in-house chef.
• Flexible working with core hours from 10am to 4pm.
• 28 days of holiday plus bank holidays, including up to 4 weeks of work-from-anywhere per year.
• Comprehensive benefit options including adjustable healthcare cover, pension, and life insurance.
• Enhanced parental leave, fertility support, and parental loss support.