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