Sofie Månsson Email & Phone Number

Malmö, SE

Malmö, Skåne, Sverige

Malmö, Skåne, Sverige

Copenhagen, Denmark

Copenhagen, Denmark

Copenhagen Area, Capital Region, Denmark

- Authoring and review of design control documentation- Conduction of design reviews- Lead Risk Management Process including risk assessment, authoring of risk management documentation in accordance with ISO14971- Contribute with change control knowledge- Independent reviewer- Audit preparation tasks- Author and contribute with input to cooperate SOPs.

Danmark

- Responsible for the design of new products e.g. reagent formulation, performance, labelling including instructions for use, packaging, design history file - Design control documentation e.g. design and development plan, requirement documentation, verification and validation protocols and reports, risk assessment and risk reports - Facilitator of design.

Lead Auditor Iso 13485:2016

Praktisk Projektledning, Project Management

Qa/Ra Leader Medical Device

Doctor Of Philosophy (Ph.D.), Pathology

PhD thesis “Invasion and Proliferation in Malignant Cells” Focused on tumor cell invasion and the cell cycle - Independently and in.

Master Of Science (M.Sc.), Chemisty

Master Thesis “Two-phase affinity purification of rabbit lacrimal gland plasma membranes and the effect on signal transduction components.