Pallav Patel Email & Phone Number

Milton Keynes, England, United Kingdom

Responsible for the medical devices training portfolio, including ownership of the course range, quality of materials and competence of trainers. The role involves identifying and evaluating training opportunities, as well as shaping the purpose, structure, and content of training courses. In addition, delivery of the medical device courses globally as an expert trainer (Both online and in person course deliveries).•Identify, evaluate, and shape training opportunities to ensure BSI are market leaders in the area of medical devices training•Keep up to date with medical device industry developments, in particular with regards to medical device standards, directives, and regulations (MDR) •Design & Develop courses using advanced learning methodologies (Accelerated Learning) and technologies •Implement trainer qualification and development requirements for new and existing medical device courses•Design and develop qualifications and assessments for all medical device courses*Oct 2018 to Apr 2021 worked for BSI independently before taking on employee status April 2021

Milton Keynes, United Kingdom

Dynamic role delivering training programs across the Medical Devices spectrum both public and company in house, within the following areas:• ISO13485:2016, implementation, clause by clause.• Internal/External ISO13485:2016 Lead auditor programs.• CE Marking, Post Market Surveillance, vigilance courses.• MDR Training - (EU) 2017/745• MDSAP Training Programs• ISO 14971 Risk Management for Medical Devices

Loughborough

Co-Founder of Self Training Tool for Cricket BattingCurrently in development, trials and testing ongoing for players ranging from juniors to professionals

London, United Kingdom

Leading all Quality aspects with the mission of implementing a QMS to ISO13485:2016 for Certification and CE Marking Solascure's products ready for market launch.

Lausanne Area, Switzerland

(3 Years in Switzerland, approx 18 months Belgium)Responsible for the development, implementation and management of a global medical device QMS certified to the ISO13485 standard and compliant to worldwide regulations (Inc. 21 CFR 820)The Management Representative for Medical Device and combination product activities. Preparing and leading Quality Management Reviews with main senior stakeholders, providing an accurate analysis of the QMS with adequate and cost-effective improvement proposals.Led the Implementation and deployment of a hybrid corporate quality system to meet the requirements of FDA CFR820 part 4 combination product requirementsResponsible for implementation of a post market surveillance program for medical devices (complaints & vigilance).Support for the design and development activities of medical devices to ensure compliance with worldwide regulations (including medical mobile Apps regulated as devices).Act as the Corporate Quality representative for FDA & EU Notified body inspections (CE marking, ISO13485).Responsible for re-developing the global complaints process for deployment across UCB, including implementation of an outsourcing model.Support the creation and maintenance of the global audit program leveraging a risk based approach for ranking and prioritisation.Support the global audit program through the execution of due diligence audits, mock inspections, routine cGMP, for cause audits and PAI inspections.

Switzerland

Global position based in Switzerland to implement, maintain and lead the quality function in order to manage all related activities for medical devices (Incl. implementation of ISO13485 and CE Mark registration).•Implementation of the medical devices function within Galderma to ensure all the relevant organisations, processes and procedures were created to operate the department within the global structure of the company. •Set up and maintenance of the Quality Management System (and all related activities) for compliance to the ISO13485 (Inc. CMDCAS) standard, the Medical Devices Directives 93/42 EEC and 21 CFR 820 (FDA) regulations.•Management of the CE certificates for the full range of injectable solutions (wrinkle fillers), Class III sterile medical devices.•Management of the key sub-contractors manufacturing medical devices.•Integration and implementation of all medical devices activities including set up of the complaints and vigilance systems, post market clinical follow up, traceability, logistics, planning and the design processes.•Supported the Regulatory Affairs function for submission of class III devices worldwide.•Project managed the integration (Inc. CE transfer) for an electronic medical device (Class IIa) into the Galderma business following an external procurement.

Management of the Global Chemicals Quality department ensuring compliance with the ISO9001 standard & cGMP regulations.

Leading the Quality & Regulatory Affairs department within Brightwake Ltd and ensure Medical Devices (Wound Dressings Class IIa, IIb) were in compliance with EU and Global Regulations.

Management role leading the Chemicals Quality Assurance function, representing Fisher Scientific UK externally and contributing to the management of the Fisher Chemicals business

A dynamic, multi-functional & hands on role ensuring that effective quality systems (ISO9001:2000 & GMP), documentation and controls are in place.

A dynamic and challenging role involving interaction with colleagues to ensure completion of regulatory documents

Bsc (Hons), Chemistry

Msc, Chemical Informatics

Education record