Paul Risborough Email & Phone Number

Blandford Forum, Gb

Selby, England, United Kingdom

Milton Keynes, United Kingdom

Manager of the Active Implantable Medical Devices team responsible for the delivery of CE certification services to Active Implantable Medical Device Manufacturers. Provide leadership, guidance and mentoring to the team. Oversee difficult regulatory decisions including CE certificate suspensions and cancellations. Liaise with the Competent Authorities including responding to COEN requests. Responsible for the financial and regulatory performance of the team. Responsible for the on-going recruitment and training of new team members.

Milton Keynes, United Kingdom

Active Implantable Devices Product Specialist responsible for the delivery of CE regulatory services to Active Implantable Device manufacturers. Qualified ISO13485 and CMDCAS QMS assessor. Qualified AIMDD 90/385/EEC assessor covering: AIMD0101 Active implantable medical devices for stimulation / inhibition; AIMD0102 Active implantable medical devices delivering drugs and other substances; AIMD0103 Active implantable medical devices substituting or replacing organ functions.

Milton Keynes, United Kingdom

Active Devices Product Specialist responsible for the delivery of CE regulatory services to Active Device manufacturers. Qualified ISO13485 and CMDCAS QMS assessor. Qualified MDD 93/42/EEC assessor covering: MD0101 Non-active devices for anaesthesia, emergency and intensive care; MD0106 Non-active instruments; MD0203 Non-active functional implants; MD1101 Devices for extra-corporal circulation, infusion and haemopheresis; MD1102 Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia; MD1103 Devices for stimulation and inhibition; MD1104 Active surgical devices; MD1301 Monitoring devices of non-vital physiological parameters; MD1302 Monitoring devices of vital physiological devices.

Senior Project Manager reporting to the Managing Director. Responsible for the delivery of engineering design projects incorporating hardware, software and mechanical systems. Involved in all aspects of product development from first meeting with client through to final product delivery. Medical device development projects included: gas powered injector, residential care home monitoring system, peripheral arterial disease diagnosis tool and gas plasma surgical tool.

Reporting to the Plant Manager and European VP. Responsible for providing engineering support to the production lines in the Andover (UK) facility. Managed the production transfer of the CUSA Ultrasonic Ablation System from USA to plants in UK and Ireland. Set company standard for Installation, Operation and Process Qualification documentation. Introduced a 21 CFR Part 11 electronic document management system.

Manager of the electronics design team reporting to the VP of R&D. Managed the design and development of the Alaris GP Large Volume Pump (LVP) electronics. Responsible for setting and maintaining the standard for electronics design within the company. Failure Mode Effects Analysis. Type testing to EN60601-1 and EN 60601-1-2.