Experience

VYAIRE MEDICAL PRODUCTS LIMITED

• 1 - 100 Employee

• Global Regulatory and Quality Director

  • Sep 2018 - Present

  Global Regulatory Affairs and Quality Assurance Director for Vyaire Medical Ltd. managing and directing the Regulatory Affairs Department and Quality Assurance Department. IRCA registered Lead Auditor covering various European Directives and Regulations, including the MDR, as well as ISO 9001, ISO 13485 , ISO 14001 and SA 8000.• Responsible for strategic planning and the control and co-ordination of attaining and maintaining regulatory and voluntary quality certifications globally. • Responsible for BREXIT compliance and Economic Operator systems implementation.• Responsible for third party accreditation in European and Asian affiliate sites to applicable regulatory requirements and advising and auditing several manufacturing sites worldwide to meet European and International standard requirements.• Presently 13 direct reports within Europe and Asia.• Responsible for Registrations and Regulatory compliance for many countries including Canada , China , Russia , Ukraine , Saudi Arabia , Israel , Middle East , Taiwan , Australia and New Zealand.



Gama Healthcare Ltd.

• Global Regulatory Affairs and Quality Assurance Director

  • Mar 2011 - Sep 2018

  Global Regulatory Affairs and Quality Assurance Director for Gama Healthcare Ltd. managing and directing the Regulatory Affairs Department and Quality Assurance Department. IRCA registered Lead Auditor covering various European Directives and Regulations as well as ISO 9001, ISO 13485 , ISO 14001 and SA 8000.• Responsible for the control and co-ordination of attaining and maintaining regulatory and voluntary quality certifications within Europe. This is for the company European and overseas sites, for pharmaceuticals, associated medical devices, drug/device combinations, biocides , cosmetics , detergents, electrical equipment and personal protective equipment.• Responsible for REACH compliance and coverage of other applicable Directives such as the WEEE, EMC and Batteries Directives.• Responsible for third party accreditation in European and Asian affiliate sites to applicable regulatory requirements and advising and auditing several manufacturing sites worldwide to meet European and International standard requirements.• Presently 18 direct reports within Europe and Asia and 4 reporting consultants.• Responsible for Registrations and Regulatory compliance for many countries including USA , Canada , China , Russia , Ukraine , Saudi Arabia , Israel , Middle East , Taiwan , Australia and New Zealand.



Ansell UK Ltd

• United Kingdom
• Architecture and Planning

• Regulatory Affairs Director EMEA

  • Aug 1997 - Feb 2011

  E.M.E.A. (Europe , Middle East and Africa) Regulatory Affairs Director for the Healthcare and PPE divisions of Ansell Ltd. (formally Pacific Dunlop) managing and directing the Regulatory Affairs Department.• Responsible for the control and co-ordination of attaining and maintaining regulatory and voluntary quality certifications within Europe. This is for the company European sites, associated medical devices, drug/device combinations and personal protective equipment.• Responsible for Biocidal Product Registrations, REACH compliance and coverage of other applicable Directives such as the WEEE, EMC and Batteries Directives.• Responsible for third party accreditation in European and Asian affiliate sites to applicable regulatory requirements and advising and auditing several manufacturing sites worldwide to meet European and International standard requirements.• Presently 6 direct reports within Europe and Asia and 3 consultants.• Responsible for Registrations and Regulatory compliance for many countries within the region including Russia , Ukraine , CIS countries , Saudi Arabia , UAE , Israel , South Africa , Kenya , Kazakhstan and Uzbekistan.• Responsibilities regarding registrations in the Asia Pacific region, including Australia and New Zealand.



British Standards Institution

• Senior Scheme Manager

  • Oct 1992 - Aug 1997

  Senior Scheme Manager and Lead auditor for the Medical Devices Notified Body within the Product Certification Division of B.S.I. (British Standards Institution)• Auditing and Administration of medical companies to the ISO 9000 and ISO 13485 series of standards, certification to the requirements of the Medical Devices Directive, the running of medical Kitemark schemes and overseeing testwork on various products.• Running in-house training and giving presentations to third parties on auditing to Medical Quality Systems requirements and the Medical Devices Directive.• Liaising with over 200 clients and sitting on various Standards Committees as the BSI representative.• Successful completion of the Lead Auditor course to become the main company lead auditor for microbiological facilities and controlled environments.• Responsibilities also included supervision of three Certification assistants and a Secretary in the day to day running of the department.• Only Scheme Manager involved in setting up the BSI Medical Division Notified Body (0086)• Involved in reviewing and re-writing sections of the MDD 93/42/EEC during its development.