Tamworth, England, United Kingdom
A pragmatic, customer focused and commercially orientated Regulatory Affairs and Quality Systems Director, with over 30 years experience in the Medical Devices sector. Excellent results in hosting external audits from multiple regulatory agencies, including FDA, MHRA and Notified Bodies. Specialities: - FDA, preparing/hosting of audits and 510 (k) - MDSAP preparation - Hosting multiple Notified Body audits with excellent results - CAPA - Post Market Surveillance - Vigilance - Building and management of multi-disciplined teams - Extensive Chinese Supply expertise - Validation of EtO cycles in multiple sites and countries - Problem resolution, experienced 'Fire Fighter' - Responsible Person for Warehousing and Distribution of Medicines - Cleanroom maintenance/validation - Registration of product world/wide in 100+ countries - Managing the Regulatory Team of six
Winding down to early retirement but still open to interesting senior roles, preferably part-time
Orthopaedic implantable replacement ligaments and instruments for EU, US, Japan and Australia Responsible for: Regulatory, Quality and H&S, a combined team of 13 direct/indirect. Orthopaedic implantable replacement ligaments and instruments for EU, US, Japan and Australia Hosted successful audits by both FDA and BSI during 2020 Led a considerable revamp of the following processes: CAPA, Change Control, Risk Management, Vigilance, Internal auditing, Goods-Inwards (reduced inspection by 90%) whilst preparing the QMS for MDSAP. Oversaw introduction of replacement electronic QMS - QPULSE