Sigrun Davidsdottir Email & Phone Number

Reykjavík, Is

Reykjavík, Is

Reykjavík, Capital Region, Iceland

R&D Systems Management is part of the Infrastructure Management Office team in Research & Development (R&D). The role includes working with cross-functional groups in various locations to organize maintenance and further development/improvement of the R&D Global Systems.• Support R&D teams with documentation requirements for regulatory compliance and according to company procedures and policies. • Train new system users.• Directly supervising R&D Systems Associate.• Manage implementation, testing, and participation in integration into other systems.• Provide advice on company technology growth opportunities. • Oversee data protection and security of R&D systems.

Reykjavík, Capital Region, Iceland

• Managed the creation, revision, distribution, and storage of technical documents using SolidWorks PDM.• Administered the SolidWorks PDM system, including user access and workflow configurations.• Ensured document accuracy, consistency, and compliance with regulatory standards.• Collaborated with teams to facilitate proper document flow.• Provided training and technical support for SolidWorks PDM users.• Developed and implemented document control procedures to enhance efficiency and accuracy.

Sweden

• Prepare a comprehensive submission package for bottled water and initiate the registration process in the United States.• Develop a checklist to ensure all necessary documentation and requirements are met for submission.• Conduct a GAP analysis to identify any discrepancies or areas needing improvement in the existing technical documentation.• Submit the prepared package to the Department of Health in New York, following their specified guidelines and procedures.• Provide guidance and coaching to a junior colleague to facilitate a transition and ensure the successful continuation of the assignment.

Gothenburg, Vastra Gotaland County, Sweden

• Update regulatory information and refine packaging and package leaflet layouts from the initial concept to the final printing stage.• Ensure the comprehensive update of technical documentation within the Quality Management System (QMS) for the specific change case.• Prepare technical documentation to meet the submission criteria for the Medical Device Regulation (MDR) review by the Notified Body, Intertek.• Facilitate the registration process for product distribution in South Korea to ensure compliance with local regulations.

Gothenburg, Sweden

• Engaged as a consultant in the dynamic MedTech industry, contributing to projects aimed at driving innovation and advancement.• Participated in the Knightec School Project, a visionary initiative dedicated to inspiring students in suburban schools to pursue higher education and cultivate an interest in technology.• Played an active role within Knightec's MDR network, fostering in-depth discussions and sharing valuable knowledge and experiences with industry peers.

Mölnlycke, Sweden

As a Regulatory Affairs Engineer, my responsibilities included:• Oversaw document submissions in multiple countries.• Updated technical and regulatory documents.• Supported MDR projects related to technical documentation.• Provided regulatory advice during weekly design change meetings.• Managed a shipping matrix.• Assisted in all aspects of company device registration.

Mölndal, Västra Götaland County, Sweden

Requirement management was used to design a high-fidelity prototype of a training tool called the STAN trainer. It is an interactive training tool for assessing Cardiotocography traces with and without ST analysis, focusing on fetal physiology. The thesis work consisted of brainstorming sessions, mind mapping, and interviews. The results were non-functional and functional requirements for implementing the STAN trainer, along with a high-fidelity prototype. I improved in requirement management, project planning, time management, and how to work in a team in the private industry.

Reykjavik, Iceland

Roles and Responsibilities included:• Assisted the Human Resources department with employee records management, payroll processing and recruitment processes.• Supported the Financials department in reporting and budgeting tasks.• Provided administrative support to Internal Services, improving office efficiency and operations.

Master’S Degree, Electrical, Biomedical Engineering

This program addresses the rising demand for efficient healthcare systems amidst increasing life expectancy. By merging engineering design.

Bachelor'S Degree, Biomedical/Medical Engineering

The program equips engineers with skills to develop innovative tools and methods for diagnosing and treating diseases, integrating.

Bachelor Of Arts - Ba, Philosophy

Completed coursework in philosophical theories, critical thinking, and ethical reasoning, focusing on developing analytical.