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 roomsRegulatory 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 response to nonconformities. Undisclosed customer – 2021