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I have over twenty years of experience in the medical device industry. I begun working with different devices (active and non-active) in the industry and became Quality and Regulatory Manager. A major part of the job involved producing documentation in English and Swedish such as work instructions and procedures, reports, product documentation and regulatory applications. I then worked with certification of medical device manufacturers at a European Notifed Body, the last five years as Certification Manager. With employees and clients in both Europe and North America the communication was mostly in English, and I produced training and information material in English as well as translated English information into Swedish.
I was a member of the editorial group for the company´s Swedish magazine MedTech Info and the related website and I also wrote many articles for the magazine and website.
I have a degree in science with a major in biology (courses included e.g. floristics, faunistics, cellbiology, zoology, evolution, ecology, immunology and “Presenting natural science” (verbal and in writing) but also social sciences, including sociology, national economy, public administration).
Early in my working life I tested a few different jobs and participated in additional trainings and educations which have given me a broad general knowledge. Today I work as a freelance providing translations, editing and proofreading services.
If required I will do a test translation of a short text (approximate 200 words) for free.
Master of Science with a Major in Biology (2001): Linköping University and Stockholm University, Sweden.
Short university coursers:
- Africa´s social and economic development: Linköping University
- Developing countries I and II: Linköping University
Numerous short courses related to quality systems and medical devices, examples:
- “Sterilization of Medical Devices”: Helsingör, Denmark, given by the University of Manchester
- “FDA´s GMP Program for Medical Devices – an Overview”: Copenhagen, AAC Consulting Group
- “Establishing Compliance With the In Vitro Diagnostic Medical Device Directive 98/79/EC (CE Marking): Copenhagen, Cameron Quality Consultants
- “Current Good Manufacturing Practice (cGMP) for Pharmaceutical and Medical Device Industry”: Amsterdam, The Center for Professional Advancement
- “Design Control & Validation for Medical Devices, A Management Tool”: Amsterdam, The Center for Professional Advancement
- "ISO 9000 Lead Auditor Training Course": Bjertorp, Sweden, CANEA Consulting Group, IRCA certified
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