Check4Cancer are a reliable and trusted provider of early cancer detection and genetic services in the UK, providing cancer services that are innovative, validated, and effective. Our clinical advisors have national and international reputations in their own cancer speciality, enabling us to provide award-winning services that are trusted by leading UK insurers, corporate clients and self-funding patients.
We are seeking a detail-oriented Regulatory and Compliance Specialist to oversee and drive our compliance efforts with UKCA, CE and FDA approval for our AIaMD (AI as medical device|) product. The role fundamentally provides technical regulatory knowledge and guidance on global regulations, specific to In Vitro Diagnostic Medical Devices (IVD) and Medical Devices (MD). As part of this, the role examines new legislation and implements it into processes if required, with initial focus on requirements as part of the IVDD to IVDR transition. The role will support new product concept work and business development (third-party sourcing) projects. The role holder advises teams on the regulatory environment and requirements associated with the products being investigated, but must also be focused on identifying compliant solutions to regulatory problems that represent the least burdensome route.
Responsibilities include:
* Act as the internal expert and advisor on key product regulatory requirements.
* Lead the effort to achieve ISO 13485 certification, ensuring the combined quality management system (QMS) meets all regulatory requirements for SaMD.
* Develop and implement risk assessment and management strategies related to information security and medical device compliance.
* Perform regular risk assessments and support risk-based decision-making throughout the organisation.
* Plan and execute internal audits to ensure compliance with key global regulations.
* Train and support staff on compliance best practices and regulatory requirements.
* Create, maintain, and manage QMS documentation, including policies, procedures, and records, to align with ISO 13485.
* Develop regulatory submissions and liaise with notified bodies and other third parties as needed for device commercialisation.
* Collaborate with cross-functional teams to embed compliance into all operations.
* Serve as the main point of contact for external auditors and regulatory bodies.
* Monitor and stay updated on relevant regulatory changes and best practices in ISO compliance and risk management.
* Propose and implement improvements to existing processes and systems to maintain competitive advantage and compliance.
Key experience required:
* Knowledge and experience applying quality system standards and regulation, e.g. ISO 13485, 21 CFR 820, MDD, MDR and IEC 62304.
* Experience in the application of design controls and risk management to medical device or SaMD design activities, e.g. writing or reviewing design plans, requirements, hazard analysis, verification and validation protocols and reports.
* Ability to understand regulatory needs and provide strategic advice.
* Experience of working to quality system procedures.
* Experience of preparing and writing standard operating procedures, templates and/or test method instructions.
* Experience of project or task prioritisation, able to handle several projects at once and work collaboratively with different teams to agreed deadlines.
* Excellent organisational, written and verbal communication skills and ability to troubleshoot.
* Strong documentation skills to ensure compliance evidence is maintained.
* Ability to lead initiatives independently while staying updated on regulatory changes in the medical device field.
Key skills you will bring to this role:
* Degree or equivalent experience in an engineering discipline (biomedical, software, electronic, mechanical, materials), quality or related subject.
* At least 3 years of experience in regulatory compliance and ISO standards implementation.
* Auditing experience.
* Experience in preparing regulatory submissions.
* Experience in working with early-stage companies, where requirements are not clearly defined and where flexibility is needed.
For more information about Check4Cancer see our website