Therese H.

I help regulated and quality-led organisations turn complex governance, risk and compliance requirements into practical systems that work day to day and withstand audit scrutiny. As a senior GRC and compliance consultant, I advise boards, executives and cross-functional teams on compliance maturity, regulatory exposure, control effectiveness and remediation priorities. My approach combines risk-based assurance, evidence review, root-cause analysis and clear executive reporting—helping leadership understand risk, establish priorities and deliver practical improvements. How I can support your organisation: - GRC framework and operating-model design - Compliance gap assessments and maturity reviews - Audit, certification and inspection readiness - Policies, procedures and internal controls - Risk registers, control testing and assurance evidence - CAPA, root-cause analysis and remediation oversight - Supplier governance and supplier-control improvement - QMS design, implementation and transformation - Board, audit committee and executive reporting - GDPR governance and operational compliance support - ISO 27001-aligned information-security governance - CSR training and responsible stakeholder engagement Sector experience: My experience includes MedTech, Software as a Medical Device (SaMD), SaaS, legal services and other regulated or standards-led environments. I understand how quality, privacy, information security, software lifecycle controls and enterprise risk need to work together across an organisation. Standards and frameworks: My experience includes ISO 13485, MDSAP, ISO 14971, IEC 62304, FDA 21 CFR Part 820, ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 17065, LEXCEL and UKDIATF. CSR training and capability building I deliver practical corporate social responsibility (CSR) training that strengthens community engagement, helps teams manage social risk and aligns operations with regulatory and stakeholder expectations. Working across legal, HSE and operational teams, I provide clear frameworks for responsible engagement, conflict prevention and credible ESG performance. Clients engage me when they need an independent senior perspective, practical remediation support or stronger evidence before an audit, certification assessment, customer review or regulatory inspection. Available for UK, EU and global engagements. Let’s discuss your current risks, deadlines and the improvements you need to achieve.