Serap Sahin Email & Phone Number

Gentofte, Hovedstaden, Danmark

• Responsible of processes in R&D ensuring efficient Design Control, Design Change and Project Management ways of working• Responsible for a global team

• Team Lead being responsible for day-to-day operations and prioritization of tasks

• Responsible for updating and maintaining innovation processes including project management, Design Control and Design Change processes• Responsible for ensuring regulatory compliance within the innovation processes (MDR, ISO13485, FDA 21 CFR Part 820)

Team Lead for an innovation project team developing class III devices.

• Executive Assistant to Head of R&D with tasks and projects related to the department and project portfolio• Main responsible in R&D for updating and maintaining innovation and business processes• Main responsible for ensuring regulatory compliance within the R&D process (MDR, ISO13485, FDA 21 CFR Part 820)• Project Manager for all cross functional R&D projects and for compliance projects e.g. MDR, ISO 13485, MDSAP• Scrum Master for all product development teams• Assist with development of local strategy in close collaboration with managers in R&D• Participate in global R&D work within the Cook Medical organisation

Roskilde

Co-founder and partner of a company that developed a medical device to help hip patients. The product was developed during studies and after raising almost 3MDKK the company was successful in selling the product in all relevant orthopaedic departments in Denmark. Money was raised from Syddansk Teknologisk Innovation (SDTI) and Region Sjælland.Some of the many successes of the company were:- Agreement and execution of Clinical Trial at Aarhus University Hospital- Production located in Turkey- Products sold in Germany by a distributor - Win the award “Årets Vækstskaber 2014” - “Growth Creator of the Year 2014” awarded by Connect Denmark.Innoneo developed innovative orthopedic products. The main product HipStop was an innovative and patented orthosis for hip surgery patients.

Roskilde

Msc, Medicine And Technology

Medicine and Technology is an interdisciplinary 2-year MSc engineering program in biomedical engineering offered by Technical University.

Project Management

Bsc, Medicine And Technology

Medicine and Technology is an interdisciplinary 3-year BSc engineering program in biomedical engineering offered by Technical University.

Studentereksamen

Activities and Societies: Student Council