Quality, Regulatory and Compliance leadership across medical device and pharma.
For nineteen years I have led quality and regulatory affairs in medical device and pharma, building the teams and quality systems that keep products safe, compliant, and trusted. I am at my best leading people, partnering across the business, and giving customers confidence in the work behind every product.
Lead compliance programs end to end: policy and procedure authorship, mapping requirements to controls, multi-jurisdiction programs across EU, UK, US, and APAC, and clear reporting to leadership.
Certified Lead Auditor in EU MDR 2017/745 and ISO 13485. Lead FDA, MDSAP, and notified-body audits, and partner closely with regulators and notified bodies including BSI, TUV, DEKRA, and LNE.
Build and lead the people and systems behind compliance: QMS, CAPA, post-market surveillance, regulatory intelligence, and the metrics that keep a program healthy and audit-ready.
That is the kind of quality and regulatory leader I have been for nineteen years, and the kind of colleague I am looking to be again.
Lead and develop a team of five owning EU MDR and UK MDR compliance across the product portfolio. Brought the portfolio into conformity, authored the governing policies and procedures, and drove a 50% reduction in reporting cycle time and a 70% reduction in contractor budget.
Led risk-based MDSAP, ISO 13485, and EU MDR audits, conducted gap analysis, and brought medical-device clients into EU MDR 2017/745 compliance ahead of notified-body and FDA audits.
Built and ran the site audit program, hosting notified bodies (DEKRA, BSI, LNE) and regulators (FDA, Health Canada), and led the MDSAP rollout across multiple sites.
Owned ISO 13485 certification maintenance across 21 countries in three regions, provided second-line oversight of global CAPAs, and developed audit responses to FDA, TGA, MHRA, and SwissMedic.
Directed quality operations and CFR 21 Part 640 compliance across multiple manufacturing facilities, and led deviation, supplier, and FDA warning-letter remediation.