Martin Cooke

Martin Cooke Email and Phone Number

Director of Operations and Regulatory Affairs at ANGLE plc @ ANGLE plc
united kingdom
Martin Cooke's Location
Guildford, England, United Kingdom, United Kingdom
Martin Cooke's Contact Details

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About Martin Cooke

A product development professional with over 30 years of technical and commercial experience across diagnostics, industrial instrumentation and telecommunications sectors internationally, with most recently, 9 years in the medical device (IVD) sector.Strong technical and commercial expertise and a track record of delivering complex multimillion-pound projects. Ability to develop strategic initiatives and drive new technology into next generation products. Proven capability in building, developing and leading high performance, multidisciplinary teams.Extensive, working knowledge of medical device regulatory systems and able to lead engagement with global medical device regulators and other regulatory agencies and notified bodies. Proven experience in the establishment and development of quality management systems for medical device manufacturers.Full product development lifecycle experience from concept through to stable manufacture.CORE COMPETENCIES• Senior level management experience across a range of technical and commercial disciplines and sectors• Linking strategic thinking and planning to practical delivery • Structured new product development (NPD) processes and projects • Project planning and delivery from concept stage through to manufacture• Product strategy, conceptualisation and requirements capture• Building, developing and leading high performance multidisciplinary teams• Supply chain development encompassing commercial, technical, quality and regulatory requirements• Medical device regulatory strategy and submission processes: FDA (including De Novo, 510(k), Pre-submissions); IVDD (98/79/EC), IVDR (EU 2017/746)• Medical device product standards: ISO13485, ISO14971, ISO62304, IEC/UL61010, IEC62366, ISO15223, ICH-GCP, CLSI• Technology commercialisation projects involving universities and specialist research centres

Martin Cooke's Current Company Details
ANGLE plc

Angle Plc

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Director of Operations and Regulatory Affairs at ANGLE plc
united kingdom
Website:
angleplc.com
Employees:
66
Martin Cooke Work Experience Details
  • Angle Plc
    Director Of Operations And Regulatory Affairs
    Angle Plc Jun 2013 - Present
    Guildford, England, United Kingdom
    Responsible for ANGLE operations including manufacturing, supply chain, logistics and engineering product development of the Parsortix® cell separation products.Responsible for the implementation of ANGLE’s quality systems and the engagement with global medical device regulators and other regulatory agencies and notified bodies. Led the team that secured the first ever US FDA product clearance (De Novo Class II classification) of the Parsortix® PC1 Clinical Device to harvest cancer cells from metastatic breast cancer patient blood samples for downstream analysis. The work included formal pre-submissions with FDA, the submission of over 400 technical reports and regulatory documents, the processing of over 16,000 samples to demonstrate device performance, together with extensive dialogue with FDA reviewers.ANGLE plcANGLE is a world leading liquid biopsy company. ANGLE's proven patent protected platforms include a circulating tumour cell (CTC) enrichment technology known as the Parsortix® system and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids/proteins.ANGLE's Parsortix® system is FDA cleared and CE-IVD marked for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating tumour cells from blood.The Parsortix® system enables a liquid biopsy to be used to provide the circulating tumour cells in a format suitable for multiple types of downstream analyses. This means that a simple peripheral blood test could be used to provide crucial medical information regarding the status of a patient’s disease over time, which offers the prospect of a new era of personalised cancer care.The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all phenotypes of CTCs as well as CTC clusters in a viable form.www.angleplc.com
  • Angle Plc
    Principal
    Angle Plc Feb 2004 - Jun 2013
    Guildford, England, United Kingdom
    Responsible for ANGLE's UK management services and consulting operations. This included marketing and business development (c£10M won contract values), client acquisition, project/programme delivery and income and key client relationship management.Specialised in the strategic development, design and implementation of innovation and knowledge transfer centred business support programmes with emphasis on high growth, technology based enterprises and academic engagements and collaborations.
  • Acterna
    Product Manager
    Acterna Nov 1995 - Jan 2003
    Plymouth, England, United Kingdom
    Product Manager responsibility for revenue stream of a core, global product line executed via the management of existing product marketing and customer support projects combined with new product strategy, market entry and technical development projects.As Project Manager, full technical development life cycle experience acquired managing a number of complex hi-tech product development projects (c$3M budget) using globally based multidisciplinary teams (up to 50 people), covering systems hardware and software, mechanical engineering and manufacturing processes.
  • Druck, A Baker Hughes Business
    Design Engineer
    Druck, A Baker Hughes Business Apr 1992 - Nov 1995
    Leicester, England, United Kingdom
    Responsible (hands-on) for the timely delivery of high accuracy electronic designs for new instrumentation products. Involved from initial product concept through to stable manufacture. Design authority for intrinsically safe instrumentation products.
  • J&S Marine Ltd
    Design Engineer
    J&S Marine Ltd Jul 1991 - Apr 1992
    Barnstaple, England, United Kingdom
    In-depth technical contribution to engineering projects as part of post design support activities for a highly resilient data network product supplied to the Royal Navy.

Martin Cooke Education Details

Frequently Asked Questions about Martin Cooke

What company does Martin Cooke work for?

Martin Cooke works for Angle Plc

What is Martin Cooke's role at the current company?

Martin Cooke's current role is Director of Operations and Regulatory Affairs at ANGLE plc.

What is Martin Cooke's email address?

Martin Cooke's email address is m.****@****plc.com

What is Martin Cooke's direct phone number?

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What schools did Martin Cooke attend?

Martin Cooke attended University Of Nottingham.

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