Tina Mygind Email & Phone Number

Regulatory Affairs for Combination Products Drug-Device (integral DDC and non-integral DDC) and accessories. (MDR Class I, IIa and IIb)Regulatory strategy/Compliance plan for US, EU, UK, CanadaPlanning and Preparing technical documentation for FDA (Device Master File - MAF)EU CE marking according to MDR 2017/745Notified body opinion according to MDR 2017/745 Article 117UKCA marking according to UK MDR 2002Canadian Medical Device License application according to SOR/98-282Material specification - review of REACH, RoHS, California proposition 65Labeling requirements in US, EU, UK and CanadaRegulatory Intelligence: Monitoring report for new regulations, standards and guidances using MedBoardPlan for new standards implementation

Regulatory affairs; product registration of in vitro diagnostic devices in Mexico, Thailand, Colombia, Korea, Vietnam, Malaysia, Peru, UAE, Saudi Arabia etcCE marking according to EU IVDR and IVDD Quality management - ISO 13485 - including internal and external auditsDevelopment of new qPCR kits, food borne pathogensWork environment and Safety

Århus Area, Denmark

Regulatory affairs; product registration of in vitro diagnostic devicesCE marking according to EU IVDR and IVDDQuality management - ISO 13485 and ISO 9001 - including internal and external auditsDevelopment and production of new qPCR kits, food borne pathogensWork environment and Safety

Vejle Area, Denmark

I lead a group of scientists and laboratory technicians. Our mission was to ensure that all laboratory and pilot process equipment and equipment/software interfaces in QC and R&D were compliant with GMP rules and Ph Eur/USP. I was responsible for people management, laboratory management and CAPEX.

Århus Area, Denmark

Århus Area, Denmark

I led an R&D group focused on in vitro screening for and testing of various natural antimicrobials as the first step in developing new antimicrobial solutions for food. The group consisted of lab technicians, scientists and students. I had the responsibility for people management, project management, scientific leadership and laboratory management.

Århus Area, Denmark

Århus Area, Denmark

I worked as a project leader within vaccine development and development of ELISA assays.

Århus Area, Denmark

Århus Area, Denmark

Århus Area, Denmark

Doctor Of Philosophy (Phd), Thesis Title: Chlamydia Pneumoniae: Pcr Detection And Cell-Mediated Immune Response To Infection

Msc Chemistry-Biotechnology, Thesis: Variability Within Four Mycoplasma Hominis Genes: A Study Of The Range Of Gene Variation

High School

Primary School