Experience

Varefakta

• Denmark
• Information Services
• 1 - 100 Employee

• Technical and regulatory consultant - food and dietary supplements

  • May 2022 - Present



Ambu A/S

• Denmark
• Medical Equipment Manufacturing
• 700 & Above Employee

• Regulatory Affairs Professional

  • Sep 2020 - May 2022

  RA Innovation Main responsibilities: - RA partner in development projects - Registration of products in e.g. EU, US, Canada and Japan - Regulatory strategies - Development of work processes and documentation RA Innovation Main responsibilities: - RA partner in development projects - Registration of products in e.g. EU, US, Canada and Japan - Regulatory strategies - Development of work processes and documentation



Cook Medical Europe

• Ireland
• Medical Equipment Manufacturing
• 200 - 300 Employee

• Regulatory Affairs Specialist

  • Mar 2019 - Sep 2020

  Product specialist, Aortic Therapies March 2019 - December 2019Product Specialist, Embolization Devices December 2019 - September 2020Primary focus on registrations in EU, Canada, Australia, Korea, China, Japan and US.Other responsibilities:- Regulatory input to development projects- Post Market Surveillance- Regulatory assessment of changes in products, marketing material and processes- Global regulations for Custom-Made Devices

• Regulatory Affairs Specialist

  • Sep 2016 - Feb 2019

  Rest-of-World regulatory submissionsOther responsibilities:- RA GDPR coordinator- Regulatory databases- Global regulations for Custom-Made Devices



FødevareBanken

• Civic and Social Organizations
• 1 - 100 Employee

• Development Consultant

  • Jan 2016 - Mar 2016

  • Satisfaction survey among partner organizations • Fundraising • Ad hoc administrative tasks • Satisfaction survey among partner organizations • Fundraising • Ad hoc administrative tasks