Experience

Pharmacolog

• Sweden
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director Quality Assurance Regulatory Affairs

  • Nov 2022 - Present

  Director QARA PRRC Director QARA PRRC



Getinge

• Sweden
• Medical Equipment Manufacturing
• 700 & Above Employee

• Perfusion Regulatory Affairs Manager

  • Mar 2022 - Present

  Regulatory Affairs Manager Operation Regulatory Affairs Manager Operation


Prevas AB
• Sweden
• Engineering Services
• 400 - 500 Employee
• QARA konsult

  • Mar 2022 - Present

Direct Healthcare Group
• United Kingdom
• Medical Equipment Manufacturing
• 1 - 100 Employee
• Quality & Regulatory Affairs Specialist

  • Aug 2021 - Mar 2022

Boule Diagnostics AB
• Sweden
• Medical Device
• 1 - 100 Employee
• Regulatory Coordinator

  • Feb 2020 - Aug 2021


Cepheid AB

• Sweden
• Medical Equipment Manufacturing
• 200 - 300 Employee

• Supervisor Reagents

  • Oct 2019 - Feb 2020

  Responsible for the first production line consist of 8-14 operators. coordinating and planning production, update methods, writing NCR/PDRs, training operators, purchasing materials, involvement in PSPs( problem solving processes) and improvements in the group and the production department and evaluation of P4Gs. Responsible for the first production line consist of 8-14 operators. coordinating and planning production, update methods, writing NCR/PDRs, training operators, purchasing materials, involvement in PSPs( problem solving processes) and improvements in the group and the production department and evaluation of P4Gs.



Cepheid

• United States
• Biotechnology Research
• 700 & Above Employee

• Manufacturing Reviewer

  • Aug 2019 - Feb 2020

  Reviewing the MFG documents, update SOPs, training operators on new methods, writing NCRs & PDRs.

• Research Scientist

  • Feb 2018 - Feb 2020

  Development of IVD device for HIV-l VL XC based on PCR. This product is a modified version of the HIV-1 product that previously was developed in the company.Being involve in development of the respiratory panel project concept phase; one of the two panel projects in the company aiming for detection of >14 pathogens within one cartridge.

• Research Associate

  • Nov 2016 - Feb 2018

  Development of IVD devices by applying PCR for:HIV-1HBVHPV