Timothy Bubb
Technical Director at IMed Consultancy Ltd- Claim this Profile
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Bio
James Knight, MSc
I worked under Tim at SLE as part of the QA group. Tim was a genuinely down to earth mentor during my time at SLE. He enabled me to learn many of the core quality engineering skills that I still utilise in my career today. Tim was also always willing to listen to new solutions to resolve any quality non conformances. Finally Tim's strength was his great hunger to learn from conferences and reading, with a goal of expanding his skillset. This led to his great knowledge with medical device regulations and techical documentation. This key attribute is something I learnt directly from him. Tim I am grateful for the mentorship and opportunity to grow that you provided for my early career.
James Knight, MSc
I worked under Tim at SLE as part of the QA group. Tim was a genuinely down to earth mentor during my time at SLE. He enabled me to learn many of the core quality engineering skills that I still utilise in my career today. Tim was also always willing to listen to new solutions to resolve any quality non conformances. Finally Tim's strength was his great hunger to learn from conferences and reading, with a goal of expanding his skillset. This led to his great knowledge with medical device regulations and techical documentation. This key attribute is something I learnt directly from him. Tim I am grateful for the mentorship and opportunity to grow that you provided for my early career.
James Knight, MSc
I worked under Tim at SLE as part of the QA group. Tim was a genuinely down to earth mentor during my time at SLE. He enabled me to learn many of the core quality engineering skills that I still utilise in my career today. Tim was also always willing to listen to new solutions to resolve any quality non conformances. Finally Tim's strength was his great hunger to learn from conferences and reading, with a goal of expanding his skillset. This led to his great knowledge with medical device regulations and techical documentation. This key attribute is something I learnt directly from him. Tim I am grateful for the mentorship and opportunity to grow that you provided for my early career.
James Knight, MSc
I worked under Tim at SLE as part of the QA group. Tim was a genuinely down to earth mentor during my time at SLE. He enabled me to learn many of the core quality engineering skills that I still utilise in my career today. Tim was also always willing to listen to new solutions to resolve any quality non conformances. Finally Tim's strength was his great hunger to learn from conferences and reading, with a goal of expanding his skillset. This led to his great knowledge with medical device regulations and techical documentation. This key attribute is something I learnt directly from him. Tim I am grateful for the mentorship and opportunity to grow that you provided for my early career.
Experience
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IMed Consultancy Ltd
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United Kingdom
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Medical Equipment Manufacturing
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1 - 100 Employee
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Technical Director
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Nov 2022 - Present
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Head of Medical Devices
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Nov 2021 - Nov 2022
RA/QA consultancy specialising in medical devices and in-vitro diagnostic products. We partner with organisations to help deliver their innovations to global markets, solve compliance issues and undertake large and small quality and regulatory projects. I specialise in consulting on medical device regulatory strategy, quality systems, regulatory compliance and clinical.
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Philips
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Netherlands
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Hospitals and Health Care
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700 & Above Employee
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Senior Manager Regulatory Affairs
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Oct 2019 - Nov 2021
Lead the regulatory function and guided the business direction as part of the senior management team of a high growth Business Unit responsible for Defibrillators, Vital Signs Patient Monitors, regulated software and multiple accessories. Supported business integration and transformation activities, leading several compliance workstreams. Supported training, development and upskilling of other departments and staff members in Quality, Regulatory, Clinical and Engineering teams. Lead the regulatory function and guided the business direction as part of the senior management team of a high growth Business Unit responsible for Defibrillators, Vital Signs Patient Monitors, regulated software and multiple accessories. Supported business integration and transformation activities, leading several compliance workstreams. Supported training, development and upskilling of other departments and staff members in Quality, Regulatory, Clinical and Engineering teams.
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SLE Ltd
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United Kingdom
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Medical Equipment Manufacturing
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1 - 100 Employee
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QA/RA Manager
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Jun 2018 - Oct 2019
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Regulatory Affairs Manager
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Feb 2016 - Jun 2018
- Medical device regulatory approvals in major regulated markets- Product regulatory and standards compliance inc MDD, RoHS and IEC 60601 series- International registrations- EU Medical Device Regulations transition- Adverse event reporting and investigation- Post Market Surveillance and product improvement- Clinical Evaluations- Virtual Manufacturing compliance- Quality system support and ISO 13485:2016 transition
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Quality Engineer
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Feb 2015 - Feb 2016
Cross functional QA/ RA/ Design at manufacturer of neonatal ventilation equipment, patient circuits and associated accessories including distributed product and own brand labelled product. Lead QA for new product development: - ISO13485 Design controls including design review and stage gating.- Design compliance to harmonised standards including IEC60601 series. - Risk management to ISO14971 including Post Market Surveillance. - Usability engineering to IEC 62366.- Project compliance to Medical Device Directive, RoHS, WEEE and other EU CE marking directives.- Design requirements traceability and generation of technical file documentation.Lead supply chain quality management: - New and existing supplier assessment, including supplier improvement activities.- Supplier auditing, manufacturing process audits and technical file content compliance reviews.- Supplier design change control and first article inspection.- Crucial supplier/ critical subcontractor identification and surveillance.Quality system review and regulatory compliance updates for;- ISO 13485- J-PAL Ord. 169 (Japan)- CMDCAS (Canada)Process design and implementation, manufacturing process control improvements.Internal auditing, procedure control and quality system management. Show less
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Quality Engineer
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Jun 2011 - Feb 2015
Quality Engineering, Quality Control for a medical device contract manufacturer specialising in rotary conversion. Supply of wound management (medical devices) and diabetes management (in vitro diagnostics) devices and components to 7 of the top 20 medical companies in the world. Head of site quality, responsible for quality and compliance at Farnham site following move of Quality Manager role to second manufacturing site. CE marking and Own Brand Labelling regulatory compliance for internally and externally developed medical products for European and Australian markets. Quality Management System design, maintenance and continuous improvement; - ISO 13485 - FDA QSR (21 CFR 820) - ISO 9001 - ISO 11137 Series - Gamma sterilisation validation and process control - ISO 14644 Series - Cleanroom monitoring and operation Design and manufacturing validation, design control and risk management. Show less
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Education
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2007 - 2011
University of Plymouth
BA, Architecture -
2005 - 2007
Alton College
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