Experience

Pharmiva AB

• Sweden
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality, Regulatory & Safety Manager

  • Oct 2022 - Present

  Quality, regulatory and safety manager Person responsible regulatory compliance (PRRC) Quality, regulatory and safety manager Person responsible regulatory compliance (PRRC)



Randstad

• France
• Human Resources Services

• Consultant Regulatory Affairs Specialist

  • Nov 2021 - Oct 2022

  Outsourced as Regulatory Affairs Specialist to: - Magle Chemoswed; Malmö Sweden: contributed to the MDR update of a MDD certified medical device - Pharmiva AB; Lund Sweden: contributed to the MDR update of a MDD certified medical device and notified body audit preparation Outsourced as Regulatory Affairs Specialist to: - Magle Chemoswed; Malmö Sweden: contributed to the MDR update of a MDD certified medical device - Pharmiva AB; Lund Sweden: contributed to the MDR update of a MDD certified medical device and notified body audit preparation



Trioworld

• Sweden
• Plastics Manufacturing
• 300 - 400 Employee

• Regulatory Affairs Manager

  • Feb 2020 - Nov 2021

  Responsible for planning, execution and follow-up of the CE certification strategy of PPE products during covid-19 pandemic. Responsible for food-plastic safety certification of PE films Responsible for planning, execution and follow-up of the CE certification strategy of PPE products during covid-19 pandemic. Responsible for food-plastic safety certification of PE films



Probi AB

• Sweden
• Biotechnology Research
• 1 - 100 Employee

• Consultant Regulatory Specialist

  • Dec 2019 - Feb 2020

  Freelance regulatory related activities at Probi AB headquarter. Freelance regulatory related activities at Probi AB headquarter.



genae (acquired by IQVIA)

• Regulatory Affairs Manager

  • Mar 2018 - Oct 2019

  Responsible for in-time regulatory submissions and making sure that they are performed according to the relevant legislations, applicable SOPs, written procedures and client agreements. Responsible for overall regulatory-related activities in clinical research, reimbursement and CE- marking projects; Responsible to guide, supervise and evaluate the performance of the Regulatory Affairs Associates.

• Regulatory Affairs Associate

  • Nov 2016 - Feb 2018

  Involved in the preparation, submission and follow-up of regulatory submissions of medical devices related clinical trials



Sanofi Genzyme

• QA Systems Officer QMS: Site Training Specialist

  • Mar 2015 - Nov 2016

  Developing, testing and implementing training processes/systems in a cGMP environment. Delivering training/presentations to >100 employees/session Developing, testing and implementing training processes/systems in a cGMP environment. Delivering training/presentations to >100 employees/session