Description
Location: Edinburgh - Hybrid or UK Remote
Sector: Regulated medical device software / AI
Stirling Q&R are partnering with a leading enterprise imaging AI platform provider, backed by a major global healthcare group, to appoint a Quality Assurance and Regulatory Compliance Manager or Specialist into a high impact individual contributor role.This position reports into the Senior VP for Governance, Risk and Compliance and sits at the heart of their quality and regulatory infrastructure across a growing portfolio of regulated software and medical device products.
The Opportunity
You will own regulatory compliance across the product portfolio and drive continuous improvement of the integrated management system. This is a genuine scope role, not a pure maintenance position.
You will also deputise for the SVP GRC in QARC matters, giving direct exposure to regulatory strategy, senior stakeholders and external partners.
Key Responsibilities
- Maintain regulatory compliance for a portfolio of medical device software and imaging products in line with overall regulatory strategy
- Lead and manage regulatory submissions and registrations across key markets (EU, UK, US)
- Support and oversee technical documentation including risk management, PMS, lifecycle and integration files
- Act as a primary interface with regulatory authorities, notified bodies, certification bodies, partners and customers, including audits and inspections
- Monitor ongoing compliance with MDR, ISO standards and partner or customer specific requirementsdeeptek+3
- Support product risk management, clinical risk review, product lifecycle management and post market surveillance activities
- Review and approve technical file documentation and other regulated documentation
- Own responses to supplier and partner quality documentation including QAAs, questionnaires and audit requests
Quality and Management System Leadership
- Act as ISO Management Representative for the organisation, ensuring processes are defined, implemented and maintained
- Coordinate management review and report on the effectiveness of the management system and improvement needs
- Lead internal audit planning, scheduling and execution and host external audits
- Oversee CAPA, non conformances, incidents, complaints and broader continuous improvement activities
- Manage change control, document control and a risk based CSV program
- Support risk based supplier evaluation, onboarding and performance monitoring
Profile They Want
- Strong experience in a QA and or Regulatory role within medical devices or software based healthcare products
- Experience developing or overseeing management systems and holding ISO Lead Auditor status in at least one relevant standard (for example ISO 13485, ISO 9001 or ISO 27001)
- Familiarity with FDA 510k and 21 CFR 820, MDR, CE marking and related guidance
- Comfortable operating across functions in a high growth, fast paced environment with multiple stakeholders
- Proven track record in managing external relationships with regulators, certification auditors, commercial partners and customers
- Confident in championing quality and compliance, communicating clearly and working both autonomously and as part of a cross functional team
Nice to have:
- Experience in SaMD or software heavy medical device environments
- Working knowledge of ISO 13485, ISO 62304, ISO 14971, ISO 27001 and ISO 9001 in practical settings
Why Work With This Client
You will be joining a business where their imaging AI platform and ecosystem of applications are central to the growth strategy, so quality and regulatory is a genuine business enabler, not a box ticking function.
For a seasoned QARC professional, this offers high visibility, broad scope across software and devices, and the chance to shape how a scaling company manages risk, compliance and innovation in a complex, evolving regulatory landscape.