Experience

Medical Device HQ
• Sweden
• Medical Equipment Manufacturing
• 1 - 100 Employee
• Medical device Trainer

  • Nov 2022 - Present


Fjord Consulting AB

• Sweden
• Medical Device

• Project Leader - Regulatory compliance

  • May 2017 - Present

  I was responsible for the regulatory compliance in the design of a new medical device. The product was to comply with FDA requirements, as well as the requirements related to the European regulations in order to be able to CE mark the product. I also acted as support to the project leader in regards to the design control process.

• Project Leader

  • Aug 2019 - Present

  This consulting assignment involves assisting a medical device company in the resign of their office facility, project leading the move of the employees to temporary , working together with the architecture to decide on colors and furniture, as well as organizing the move back to the new office. It is a different project than I usually lead, and I am enjoying the creative process!

• Regulatory & Design Control Specialist

  • Apr 2014 - Present

  As a team member in a product development project of Class IIa and Class III medical devices I support the customer with design control documentation as well as regulatory support.

• ISO 13485 compliance

  • Feb 2019 - Nov 2019

  During this assignment I assisted and guided my customer in updating their ISO 9001 system to be compliant to ISO 13485.

• Design Review - Independent Reviewer

  • May 2016 - Aug 2019

  As Independent Reviewer, I performed a review of all documentation that were required according to the applicable directives and standards, in order to ensure that the medical device was in compliance. I also attended the Design review meetings.

• Project Leader - Medical Device Production Process Validation

  • Nov 2015 - Aug 2019

  As project leader of a revalidation of a medical device production process I co-ordinated all IQ/OQ/PQ activities in the validation, as well as compiled required protocols and reports.

• Medical Device - Quality Management & Design Control

  • Sep 2015 - Feb 2018

  I am responsible for the compilation of a quality management system that complies to ISO 13485, and am a team member in the development project of a Class IIa medical device.

• Interim Quality Manager

  • Mar 2015 - Oct 2015

  I took on the role of the quality manager, as the current quality manager was on paternity leave.

• Design Control & Usability Specialist

  • Oct 2013 - Aug 2014

  In a development project the company developed Class I and Class IIa products. I was responsible for compiling all documentation required in the technical file as well as leading the usability activities.

• Medical device - Interim Quality Manager & Design Control

  • Jun 2013 - May 2014

  In this assignment I acted as Interim Quality Manager as the current manager was on maternity leave. During this time we compiled a quality management system and received an ISO 13485 certificate. I was also involved in the development of a Class III device and was responsible for the compilation of the Design Dossier for the product.



Getinge Sterilization AB

• Quality Manager

  • May 2011 - Sep 2013

  During my time at Getinge Sterilization AB the organization went through several organizational changes. As part of the management team we led the organization through these changes. I led the work of implementing a new process based quality management system, fulfilling the needs of internal and external customers, as well as regulatory requirements (ISO 13485, ISO 9001, 21 CFR part 820). In my role as Quality manager I led a team of approximately 20 people, direct and indirect reports.

• Chief Project Manager

  • Nov 2010 - Jun 2011

  As Chief Project Manager at Getinge Sterilization I led a team in the development of a new platform for the company’s products. It was a global project, including 3 different sites and a multitude of product combinations and sub projects.



SemconCaran Medical Life Science

• Senior Consultant

  • Sep 2009 - Nov 2010

  During my time as Senior Consultant at Semcon Life Science I was involved in contact with, selling of resources as well as performing training and projects together with customers. During my time as Senior Consultant at Semcon Life Science I was involved in contact with, selling of resources as well as performing training and projects together with customers.



HemoCue AB

• Sweden
• Medical Equipment Manufacturing
• 200 - 300 Employee

• New Products & Project Manager

  • Jan 2006 - Sep 2009

  The assignment included leading projects where products developed through external companies were to be distributed by HemoCue AB, as well as leading projects where current products where adapted to new markets. As project leader I coordinated activities between and within the companies. I also coordinated the strategic group for pre-project management, including evaluation of new ideas, documentation and reporting.

• Assistant Marketing Manager

  • Jun 2001 - Dec 2006

  80% of my time was spent in development projects where my main role was to define and follow-up on market requirements. I also produced the market material for the new products, performed validation studies and together with the sales team launched the products.