Description

Experience delivering governance, risk and quality solutions within regulated environments, with a strong focus on medical devices and software (SaMD). I have led the design and remediation of quality management systems aligned to ISO 13485 and MDSAP, integrating software lifecycle requirements under IEC 62304 and risk management frameworks in accordance with ISO 14971. My work includes developing audit-ready documentation, strengthening CAPA and supplier control processes, and building traceability across design, risk and verification activities. I have supported organisations in achieving audit readiness, resolving nonconformities and implementing structured, regulator-aligned systems that withstand scrutiny from notified bodies and regulatory authorities, including FDA expectations under 21 CFR Part 820.

Languages

English
Native or bilingual

Workplace preferences

Remote only

Primarily works remotely

Freelance.
Compliance, Quality & Project Management Advisor
MEDICAL
January 2017 - Today (9 years and 5 months)
London, United Kingdom
Senior advisor to regulated organisations on governance frameworks, compliance operating models and ISO certification.
• • Designed risk-based compliance and audit frameworks across legal and regulated sectors.
• • Advised extensively on SRA Code of Conduct, client care, risk and controls.
• • Delivered ISO 9001 , 14001 , 22301 , 27001 implementation, UKDIATF, audits and continuous improvement.
• • Developed governance documentation, risk registers, policies and assurance programmes.
• • Led audit teams providing impartial governance insights to senior leadership.
• • Strengthened AML, sanctions, CDD/PEP, ABC, conflicts and onboarding controls.
• • Supported UKDIATF audit and compliance for SaaS ID verification and PAS 1296 alignment.
• • Delivered AgilePM-based operational and compliance transformation.
• • SRA file review and complex case review; costing review.
• • MDSAP / FDA / ISO 13485 / Medical Devices Class ll. IEC 62304; ISO 14791
MDSAP & ISO 13485 Audit Readiness Integrated QMS, Software & Risk Frameworks Regulatory Risk & Compliance Governance CAPA & Audit Remediation Medical Device Documentation & Traceability
Institute Of Export & International Trade (IOE&IT)
Senior Compliance Officer - Contract
January 2023 - January 2024 (1 year)
Directed compliance governance, audit strategy and ISO certification for a national professional body.
• • Led ISO 9001 , 14001 , 27001 implementation and audit readiness.
• • Designed governance workflows, operational systems and assurance frameworks.
• • Delivered OFSTED/OFQUAL compliance support across apprenticeships and training.
• • Produced Board-level compliance, risk and audit reporting.
• • Led creation of an industry Quality Standard incl. scope, KPIs, risk governance, due diligence and budget oversight.
• • Established supplier audit criteria and multi-vendor governance.
• • Developed governance documentation, risk registers, policies and assurance programmes.
• • Led audit teams providing impartial governance insights to senior leadership.
• • Strengthened AML, sanctions, CDD/PEP, ABC, conflicts and onboarding controls.
• • Supported UKDIATF audit and compliance for SaaS ID verification and PAS 1296 alignment.
LEXCEL. SGS UK LTD
Lead Auditor
January 2004 - January 2008 (4 years)
Pacific Northwest, Cariboo, BC V0L 1H0, Canada
• • Client auditing – local, national and international clients
• • Client management / account management
• • Leading and management of team audits – ISO 9001 & LEXCEL
• • Team member on audits – ISO 14001 , 45001 and 27001 .
• • Project and team management