Simon Bjørn Larsen

Senior Consultant

Documentation | GMP | Project management

Summary

Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Simon’s working experience includes developing and managing Quality Management Systems, project management, handling of nonconformities and change controls, internal auditing and qualification of clean room areas, equipment and software.

Simon has experience working with the regulatory requirements laid out in ISO 13485, 21 CRF 820, MDSAP, MDD/MDR, ISO 14971, ISO 9001, ISO 11607 and EU-GMP, including Annex 1.
As a person he is dedicated, reliable, and has a high commitment to reaching the goals set up within the given timeframes.

Special Competences

  •  Line & project management within the pharmaceutical and medical device industry
  • Quality Management Systems: Development and management of Quality Management Systems
  • GMP: Support for production, quality assurance, quality control, warehouse and transportation, including preparation of procedures, training of personnel, handling of nonconformities and change controls.
  • Documentation: Preparation of documentation for regulatory authorities
  • Qualification and validation of equipment and clean rooms
  • Regulatory Affairs: Medical device registration in China and Europe, incl. Brexit issues
  • Personal: Structured problem solving, maintain overview, solution oriented and persistent in completing assignments

Project Experience

  • Regulatory Affairs, MDR submission
    Preparation and submission of technical documentation for MDR approval of Class IIb medical devices.
    Coordination and preparation of responses to nonconformities.
    Undisclosed customer – 2021-2023
  • Developing and implementing system for product inactivation
    Preparing and implementing procedure and checklists for inactivation of products, including identification and obsoletion/update of all external and internal documents related to inactivated products.
    Undisclosed customer – 2021
  • Regulatory Affairs, workflow optimization
    Optimization of workflows in a Regulatory Affairs Department, including preparation of procedures and checklists to comply to applicable regulatory requirements, incl.:
    – Regulatory impact assessment of change requests
    – Checklist for regulatory approval of Label/IFU
    – Checklist for regulatory approval of Marketing Materials
    Undisclosed customer – 2020
  • MDSAP-certification
    Gap-analysis of MDSAP-compliance, main contact to Notified Body, manage Stage 1 and Stage 2 audits resulting in 0 nonconformities.
    William Cook Europe – 2019
  • QA approval of qualifications
    QA approval of qualifications of packaging equipment and software A variety of projects has been carried out.
    Novo Nordisk A/S – 2015 – 2016
  • Qualification of passive cold storage transportation system
    Determining user requirement specifications, selection of system, qualification and validation of system.
    Region Zealand, Hospital Pharmacy – 2014 – 2015
  • Design and implementation of new clean room areas, ISO Class 5-8
    Responsibility for budget, timelines, hiring of personnel and having technical responsibility for qualification and validation, defining workflow and training of personnel.
    Obtained approval for production of sterile pharmaceuticals from the Danish Medicines Agency.
    Region Zealand, Hospital Pharmacy – 2005 – 2009
  • Upgrading workflow and documentation for inspection readiness
    Revising work procedures, rewriting SOPs, training of personnel, upgrading of documentation to meet applicable regulatory requirements.
    Region Zealand, Hospital Pharmacy – 2004
  • Implementation of new Medical Device in production
    Introduction of a new medical device in production, including specifying requirements for clean rooms and equipment, defining documentation requirements, writing SOPs and training of personnel.
    Ferrosan A/S – 2000 – 2001

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