Agnieszka Romowicz
Product Compliance Manager at Medicalgorithmics S.A.- Claim this Profile
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Polish Native or bilingual proficiency
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English Professional working proficiency
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Russian Elementary proficiency
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Bio
Alicja Wianecka
I was working closely with Agnieszka for 2,5 years during various stages of bringing medical products to the international markets. It was a very smooth and satisfactory cooperation. Agnieszka is passionate and dedicated to her work. She is professional and open-minded, which enables her to find best solutions and inspire to take responsibility of one's work. Her communication style is elegant yet direct, which helps a lot in product development in fast-paced and changing agile environment. On top of that, she constantly expands her knowledge, which results in knowing her field very well. I can definitely recommend working with Agnieszka.
Alicja Wianecka
I was working closely with Agnieszka for 2,5 years during various stages of bringing medical products to the international markets. It was a very smooth and satisfactory cooperation. Agnieszka is passionate and dedicated to her work. She is professional and open-minded, which enables her to find best solutions and inspire to take responsibility of one's work. Her communication style is elegant yet direct, which helps a lot in product development in fast-paced and changing agile environment. On top of that, she constantly expands her knowledge, which results in knowing her field very well. I can definitely recommend working with Agnieszka.
Alicja Wianecka
I was working closely with Agnieszka for 2,5 years during various stages of bringing medical products to the international markets. It was a very smooth and satisfactory cooperation. Agnieszka is passionate and dedicated to her work. She is professional and open-minded, which enables her to find best solutions and inspire to take responsibility of one's work. Her communication style is elegant yet direct, which helps a lot in product development in fast-paced and changing agile environment. On top of that, she constantly expands her knowledge, which results in knowing her field very well. I can definitely recommend working with Agnieszka.
Alicja Wianecka
I was working closely with Agnieszka for 2,5 years during various stages of bringing medical products to the international markets. It was a very smooth and satisfactory cooperation. Agnieszka is passionate and dedicated to her work. She is professional and open-minded, which enables her to find best solutions and inspire to take responsibility of one's work. Her communication style is elegant yet direct, which helps a lot in product development in fast-paced and changing agile environment. On top of that, she constantly expands her knowledge, which results in knowing her field very well. I can definitely recommend working with Agnieszka.
Credentials
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Professional Scrum with User Experience (PSU I)
Scrum.orgApr, 2021- Nov, 2024 -
Wymagania nowego rozporządzenia 2017/745 dla wyrobów medycznych
TUV NordOct, 2019- Nov, 2024 -
Ocena kliniczna wyrobów medycznych - wymagania i ćwiczenia praktyczne
TUV NordSep, 2019- Nov, 2024 -
ISO 13485:2016 Medical Device Management Systems Internal Auditor
BSIAug, 2018- Nov, 2024 -
Chemical Sensors and Biosensors
Warsaw University of TechnologyNov, 2014- Nov, 2024 -
IELTS
British CouncilMar, 2014- Nov, 2024
Experience
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Medicalgorithmics S.A.
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Poland
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Software Development
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1 - 100 Employee
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Product Compliance Manager
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May 2021 - Present
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Senior Product Compliance Engineer / UX Researcher
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Jul 2020 - May 2021
Define regulatory requirements for SaMD (Software as a Medical Device) Creation and verification of product documentation for compliance with IEC 62304 Assistance in defining product requirements considering the requirements to be met by the medical product Conducting risk analysis in accordance with ISO 14971As a UX : Own the end-to-end user research lifecycle and optimize processes to make it easier for teams to apply research in the medical software development cycle. Identify and prioritize research opportunitiesConduct heuristic evaluations, cognitive walkthroughs, refine user personasBuild and maintain the UX research repositoryCollaborating with the scrum team developing a medical productCreating docuemntation for compliance with standards IEC 60601-1-6, IEC 62366 and other usability gudiances Show less
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Certification & Quality Systems Engineer
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Jul 2018 - Jul 2020
Developed regulatory strategies for US, EU and Canada. Prepared premarket notification 510(k) for Class II medical device. Provided risk management guidance as well as prepared and updated multiple risk management files. Conducted internal audits including design control, document control, IT, software development process and quality system according to ISO 13485, ISO 9001, Medical Device Single Audit Program (MDSAP). Delivering objectives to strict budgets, deadlines and servicce level agreements.Collaborated with teams to discover and deliver the best solution to the market presented by the product team lead and the business. Show less
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UL Solutions
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United States
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International Trade and Development
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700 & Above Employee
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Associate Project Engineer
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Apr 2017 - Jul 2018
Demonstrated project management skills, such as supporting multiple projects simultaneously under tight deadlines while providing attention to detail and high quality work in a dynamic environment. Establishing, tracking, and maintaining project schedules.Experience with ISO 14971 Risk Management for medical devices.
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Engineer
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Aug 2015 - Mar 2017
Conducted the medical device evaluation according to IEC 60601-1 and selected Collateral and Particular standards. Performed electrical safety testing. Communicated project status and test results to client, sales personnel, and management throughout testing.
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International Research Center on Mathematics and Mechanics of Complex Systems “M&MoCS”
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Cisterna di Latina, Italy
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Research Program Visiting Student
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Feb 2015 - Mar 2015
Mathematical modeling of growth and mechanics of reconstructed living tissues in COMSOLMultiphysics Mathematical modeling of growth and mechanics of reconstructed living tissues in COMSOLMultiphysics
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Education
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2017 - 2018
AGH University of Science and Technology
Postgraduate studies, Biomaterials - materials for medicine -
2014 - 2016
Warsaw University of Technology
Master’s Degree, Biomedical/Medical Engineering -
2010 - 2014
Technical University of Wroclaw
Engineer's degree, Biomechanics/Biomedical/Medical Engineering
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