Louise Bateman

Quality Assurance and Regulatory Affairs Manager at Bedfont Scientific Ltd
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Contact Information
us****@****om
(386) 825-5501
Location
UK

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Jason Smith

Louise is a valued member of the management team within the Bedfont family. She has a hunger to learn and has developed her expertise in RA & QA hugely since joining Bedfont as a Sales Administrator back in 2009. Nowadays she heads up our RA & QA team ensuring our products are compliant at all times, unlocking the doors to new markets through product registrations and implementing our QMS system for continuous improvement across the board.

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Credentials

  • Clinical Evaluation Reports
    MAETRICS
    Jun, 2017
    - Oct, 2024

Experience

    • United Kingdom
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Quality Assurance and Regulatory Affairs Manager
      • Oct 2014 - Present

      Ensuring that all the company's products comply with the regulations of the MDD.Undertaking and managing regulatory inspections, such as internal and external audits.Implementation of a new quality system covering ISO13485 and 9001.Maintaining, auditing and updating company procedures.Maintaining and updating all technical files for the company products.Managing the QA & RA department for the company, directly responsible for 3 employees.

    • Regulatory Affairs Administrator
      • Mar 2012 - Oct 2014

      Ran the change note system for the entire company, including creating, chasing and processing all change notes.Submitting registration documentation to customers for specific products and managed all documents going to the solicitor, foreign common wealth and embassies.Regularly liaised with distributors, regulatory agencies, sales and technical.Entrusted to manage, maintain and update a datasheet for all critical components. Additionally dealt with vigilant issues, which included informing competent authorities, submitting documentation and issuing field safety notices as required.Assisted the RA manager as required.

    • UK Sales & Exhibition Coordinator
      • Jan 2011 - Jul 2011

      Responsible for booking stands at worldwide exhibitions, liaising with management companies for exhibitions organizers, raising orders for equipment to be sent to exhibitions on a timely manner and dealing with couriers and freight-forwarders to ensure the shipment of exhibitions goods was swift and successful. Also checked stock coming back from exhibitions to ensure there were no losses or damages.

    • Sales Administrator
      • Nov 2009 - Jul 2011

      Responsible for receiving and processing orders from sales, both import and export, via Lakeview. Entrusted to keep the company's client database and files in order, maintaining records and used Sage ACT to do so.Dealt with the company's courier and freight-forwarder accounts and all logistics for all orders.

    • United Kingdom
    • Construction
    • 1 - 100 Employee
    • Customer Service Administrator
      • Oct 2007 - Nov 2009

      Account manager for 5 main construction contractors. Looked after orders, customer complaints, late deliveries, quotes, stock inquiries. Conducted site visits and also worked with key suppliers to drive promotions. Also responsible for entertaining important customers with the key rep. Account manager for 5 main construction contractors. Looked after orders, customer complaints, late deliveries, quotes, stock inquiries. Conducted site visits and also worked with key suppliers to drive promotions. Also responsible for entertaining important customers with the key rep.

    • United States
    • Writing and Editing
    • Sales admministrator
      • 2005 - 2007

      Entrusted to deal with large clients such as Tesco, Sainsburys, Asda etc. Responsible for receiving and following through all orders to fit out new and existing shelving in their stores.

    • Stock Controller
      • 2005 - 2007

      Managed an 86,000 square ft warehouse. Responsible for all incoming and outgoing stock, monthly stock takes, speaking to the main warehouse, receiving orders and dispatching them to the warehouse supervisors, booking in purchase orders and moving stock on the in-house automated system. Dealt with couriers as well as managed the warehouse office.

    • Office Junior
      • 2003 - 2005

      Dealt with office administration; taking calls from construction companies, loading orders, chasing orders, making tea, photocopying, filing etc. Dealt with office administration; taking calls from construction companies, loading orders, chasing orders, making tea, photocopying, filing etc.

Education

  • North West-Kent College
    Junior Secretary Course Level 1 Diploma, Legal Administrative Assistant/Secretary
    2002 - 2003
  • Thamesview Secondary School
    1997 - 2002

Community

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