Los Angeles, California, United States
25 years Regulatory Affairs experience within Pharmaceuticals, CRO and most significantly in IVD medical devices. Growth and leadership of an IVD Notified Body (NB) team to designate two NBs to the EU IVD Regulation (IVDR). Regulatory Expertise: In Vitro Diagnostics – Notified Body requirements / CE marking / IVDR Applications & requirements / IVDD / Technical Documentation / design reviews / verification & validation strategy / risk management / FDA 510(k) & PMA / ‘Rest of World’ documentation / labelling / medical device reporting & vigilance / Post-market under the IVDR Pharmaceuticals – development strategy / clinical trials / technical dossier compilation & review / post-licensing maintenance / variations / labelling Leadership: Team expansion and successful growth. Technical Expertise: Technical dossier writing / technical summaries / review of technical information / summarising regulatory intelligence information / strategy planning / verification/validation planning (IVD/MD) / clinical trials (pharmaceutical/MD) / protocol review / Technical file compilation and review (IVD/MD) / Risk Management / 510(k) & PMA drafting and collation / FDA electronic submissions (IVD/MD) / Vigilance reporting / Post-licensing maintenance / labelling review & compliance
Responsible for all regulatory activities associated with IVD medical devices for Europe • Grow consultancy business for IVDs in Europe • Provide strategic advice to IVD clients, covering EU IVDR, UKCA, US FDA. • Technical documentation, FDA Pre-Sub; IVDR impact on Clinical Trials; Companion Diagnostics (CDx) support; Pharma company training on IVDR; external presentations. • Co-Chair of ABHI IVD Regulatory working group.
Responsible for all regulatory and compliance for IVD CE marking operations • Lead the implementation of the IVD Regulation (IVDR) for internal regulatory compliance and external representation to Competent Authorities • Represent IVD for UK Approved Body regulatory activities • Represent BSI on NB Coordination Group, IVD working groups and MDCG meetings
Growing and leading the operational IVD technical team • Recruitment and development of team to meet the requirements of the IVDR (CE marking); expansion of team from 7 to 25 experts, and PM and training personnel. • Working to deliver reviews to timelines, responsible for budgets and financial targets. • IVDR NB representative for TeamNB and MDCG groups; EMA CDx working group. • Presentations at external conferences & courses (such as RAPS, Euro RAPS, MedTech Summit, TOPRA training courses). • Lead in Competent Authority audits; Joint Assessments for IVDR designations (two NBs).
IVD Technical specialist; Scheme Manager for BSI Notified Body certification work • Compliance and certification work for IVD products; Scheme Manager • Training & support for new IVDR transition; including new IVD training courses and external webinars. Representative at BIVDA and IVD NB Working Groups; drafting of Companion Diagnostics white paper.
Regulatory strategy for a novel IVD assay; setting up a Quality Management System. • Regulatory development strategy for EU and US approvals for start-up company. • Establishing a QMS to ISO 13485 & ISO 17025. Risk management (ISO 14971) incorporation into design and development for IVD intended for Alzheimer’s disease.
• Providing regulatory affairs consultancy to various companies, primarily within the medical device and IVD sector; ISO13485 compliance; Risk management ISO 14971; FDA 510(k) submissions; CE-marking/Technical File reviews; labelling compliance. • Support for drug clinical studies (e.g. for an active-implantable medical device), ISO 14155 training to CRO staff for drug trials involving medical devices.