James Allard
Regulatory Affairs and Quality Consultant at JReg Consultancy Ltd- Claim this Profile
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Bio
Credentials
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Drug-Device Combination Products Quality & Regulatory Requirements
Symmetric TrainingJun, 2023- Nov, 2024
Experience
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JReg 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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Regulatory Affairs and Quality Consultant
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Jul 2022 - Present
Consultant working for medical device manufacturers in a variety of sectors, such as: • Ophthalmic - non-contact tonometers and ocular ultrasonography. • Perinatal - foetal blood sampling. • Neurological - cerebrospinal fluid pressure measurement and removal. • Rehabilitation - treatment of urinary incontinence in women through neuromuscular stimulation. Responsibilities include: • MDR gap assessments, strategy planning and implementation. • Technical File development… Show more Consultant working for medical device manufacturers in a variety of sectors, such as: • Ophthalmic - non-contact tonometers and ocular ultrasonography. • Perinatal - foetal blood sampling. • Neurological - cerebrospinal fluid pressure measurement and removal. • Rehabilitation - treatment of urinary incontinence in women through neuromuscular stimulation. Responsibilities include: • MDR gap assessments, strategy planning and implementation. • Technical File development, writing, review and remediation. • Authoring of Quality Management System procedures. • Preparation of regulatory strategies to support submissions in EU, US, UK and Canada. • UKCA marking and UKRP regulatory support. Show less Consultant working for medical device manufacturers in a variety of sectors, such as: • Ophthalmic - non-contact tonometers and ocular ultrasonography. • Perinatal - foetal blood sampling. • Neurological - cerebrospinal fluid pressure measurement and removal. • Rehabilitation - treatment of urinary incontinence in women through neuromuscular stimulation. Responsibilities include: • MDR gap assessments, strategy planning and implementation. • Technical File development… Show more Consultant working for medical device manufacturers in a variety of sectors, such as: • Ophthalmic - non-contact tonometers and ocular ultrasonography. • Perinatal - foetal blood sampling. • Neurological - cerebrospinal fluid pressure measurement and removal. • Rehabilitation - treatment of urinary incontinence in women through neuromuscular stimulation. Responsibilities include: • MDR gap assessments, strategy planning and implementation. • Technical File development, writing, review and remediation. • Authoring of Quality Management System procedures. • Preparation of regulatory strategies to support submissions in EU, US, UK and Canada. • UKCA marking and UKRP regulatory support. Show less
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SENER Diagnostics
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Spain
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Biotechnology
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1 - 100 Employee
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Product Assurance and Regulatory Affairs Manager
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Dec 2021 - Jun 2022
• Managed the Quality Control, Complaints, Validation and Regulatory teams. • Quality and Regulatory Lead for the Autoplak automated plate streaking system (launched in EU in 2017, distributed by Beckman Coulter Diagnostics) and early-stage development projects. • Responsible for the Autoplak IVDR Technical File and CE marking. • Defined and implemented processes, quality plans and templates. • Managed non-conformities, CAPAs and deviations. • Managed, approved and simplified… Show more • Managed the Quality Control, Complaints, Validation and Regulatory teams. • Quality and Regulatory Lead for the Autoplak automated plate streaking system (launched in EU in 2017, distributed by Beckman Coulter Diagnostics) and early-stage development projects. • Responsible for the Autoplak IVDR Technical File and CE marking. • Defined and implemented processes, quality plans and templates. • Managed non-conformities, CAPAs and deviations. • Managed, approved and simplified the Autoplak supply chain. Show less • Managed the Quality Control, Complaints, Validation and Regulatory teams. • Quality and Regulatory Lead for the Autoplak automated plate streaking system (launched in EU in 2017, distributed by Beckman Coulter Diagnostics) and early-stage development projects. • Responsible for the Autoplak IVDR Technical File and CE marking. • Defined and implemented processes, quality plans and templates. • Managed non-conformities, CAPAs and deviations. • Managed, approved and simplified… Show more • Managed the Quality Control, Complaints, Validation and Regulatory teams. • Quality and Regulatory Lead for the Autoplak automated plate streaking system (launched in EU in 2017, distributed by Beckman Coulter Diagnostics) and early-stage development projects. • Responsible for the Autoplak IVDR Technical File and CE marking. • Defined and implemented processes, quality plans and templates. • Managed non-conformities, CAPAs and deviations. • Managed, approved and simplified the Autoplak supply chain. Show less
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Vectura Group
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United Kingdom
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Quality Manager
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May 2019 - Nov 2021
• Managed a high-performing team of Quality Engineers. • Ensured products were designed and tested in accordance with applicable industry standards, regulatory, company and customer requirements. • Quality Representative across multiple projects and device platforms, such as: - Next generation nebuliser devices: a successful outcome was essential to Vectura’s CDMO business model. - Development of connected DPI devices for health and well-being services. … Show more • Managed a high-performing team of Quality Engineers. • Ensured products were designed and tested in accordance with applicable industry standards, regulatory, company and customer requirements. • Quality Representative across multiple projects and device platforms, such as: - Next generation nebuliser devices: a successful outcome was essential to Vectura’s CDMO business model. - Development of connected DPI devices for health and well-being services. - Introduction of semi-automated DPI and nebuliser assembly lines. - Consolidation of the existing MasterControl and BM Flow into a single EDMS. - Development of an Open-Inhale-Close (OIC) DPI device for the US market. • Created and managed Quality Technical Agreements, departmental Quality metrics and generated/supported Technical Files, DHFs, change controls, non conformances, deviations, CAPAs and SCARs. • Responsible for internal audits and Notified Body/customer audits. • Trained and coached staff on procedures and processes, monitored and continuously improved staff engagement with the Quality department. • Updated and supported maintenance of the Quality Management System. • Responsible for Quality and Continuous Improvement activities, such as the removal of inspections for incoming device components and Gemba walks.
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Senior Manager / Laboratory Manager
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Jun 2018 - May 2019
• Managed a high-performing team of Scientists and Engineers based in the UK and Germany. • Change Leader for R&D Productivity Transformation (Continuous Improvement). • Project Manager for GyroPLUS® (variant of GyroHaler®). • Responsible for design proving and verification activities. • Supervised work to achieve specific objectives and meet defined deadlines. • Responsible for the laboratories, calibration and Data Integrity at Cambridge. • Reviewed and authored Device… Show more • Managed a high-performing team of Scientists and Engineers based in the UK and Germany. • Change Leader for R&D Productivity Transformation (Continuous Improvement). • Project Manager for GyroPLUS® (variant of GyroHaler®). • Responsible for design proving and verification activities. • Supervised work to achieve specific objectives and meet defined deadlines. • Responsible for the laboratories, calibration and Data Integrity at Cambridge. • Reviewed and authored Device Requirements and Functional Specifications. • Planned and allocated work as appropriate and resolved underlying issues. • Direct contact and/or backroom staff for external audits. • Generated and reviewed technical protocols and reports.
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Manager / Laboratory Manager
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Jan 2017 - May 2018
• Managed a high-performing team of Scientists and Engineers based in the UK and Germany. • Responsible for design proving and verification activities. • Supervised work to achieve specific objectives and meet defined deadlines. • Responsible for the laboratories, calibration and Data Integrity at Cambridge. • LOMI Subject Matter Expert (design proving and verification) and backroom staff for FDA audit. • Planned and allocated work as appropriate and resolved underlying… Show more • Managed a high-performing team of Scientists and Engineers based in the UK and Germany. • Responsible for design proving and verification activities. • Supervised work to achieve specific objectives and meet defined deadlines. • Responsible for the laboratories, calibration and Data Integrity at Cambridge. • LOMI Subject Matter Expert (design proving and verification) and backroom staff for FDA audit. • Planned and allocated work as appropriate and resolved underlying issues. • Direct contact and/or backroom staff for external audits. • Generated and reviewed technical protocols and reports.
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Team Leader / Laboratory Manager
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Oct 2011 - Dec 2016
• Supervised Scientists, Engineers and Interns and allocated work as appropriate. • Risk Assessment Team Leader for LOMI30 (variant of the LOMI device). • Author of Risk Management documentation for LOMI30, such as the Risk Management Plan, Top-Level Risk Analysis, Design FMEA and Risk Register. • Conducted and presented analyses on data, including statistical analysis and interpretation. • Provided training in a range of engineering and scientific skills.
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Senior Scientist
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Oct 2009 - Oct 2011
• Supervised Scientists and Interns and allocated work as appropriate. • Conducted and presented analyses on data, including statistical analysis and interpretation. • Provided training in a range of engineering and scientific skills. • Conducted DPI mechanical design proving and verification activities. • Tested DPIs via NGIs, ACIs and Emitted Dose. Analysis was performed by HPLC.
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Pharmaceutical Scientist
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Aug 2006 - Oct 2009
• Conducted and presented analyses on data, including statistical analysis and interpretation. • Provided training in a range of engineering and scientific skills. • Conducted DPI mechanical design proving and verification activities. • Tested DPIs via NGIs, ACIs and Emitted Dose. Analysis was performed by HPLC.
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3M
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United States
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Industrial Machinery Manufacturing
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700 & Above Employee
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Quality Control Analyst
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Jan 2005 - Aug 2006
• Tested Metered Dose Inhalers (MDIs) via analytical techniques such as ACIs and Emitted Dose. Analysis was performed by HPLC, GC and IR. All testing was in compliance with GMP regulations. • Generated and reviewed documents such as SOPs, test procedures, reports and deviations. • Tested Metered Dose Inhalers (MDIs) via analytical techniques such as ACIs and Emitted Dose. Analysis was performed by HPLC, GC and IR. All testing was in compliance with GMP regulations. • Generated and reviewed documents such as SOPs, test procedures, reports and deviations.
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Charnwood Discovery
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United Kingdom
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Research Services
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1 - 100 Employee
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Synthetic Organic Chemist
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Aug 2004 - Dec 2004
• Synthesised heterocyclic, aromatic and aliphatic compounds. Syntheses ranged from a few grams to one hundred grams and were typically multi-step. Product analysis was performed by NMR and LC-MS. • Synthesised heterocyclic, aromatic and aliphatic compounds. Syntheses ranged from a few grams to one hundred grams and were typically multi-step. Product analysis was performed by NMR and LC-MS.
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Education
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2000 - 2004
Loughborough University
Doctor of Philosophy (PhD), Organic Chemistry -
1999 - 2000
Loughborough University
Master of Science (MSc), Analytical Chemistry and Instrumentation -
1996 - 1999
Loughborough University
Bachelor of Science (B.Sc.), Chemistry, Physical Education and Sports Science
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