QM/RA Manager
Reykjavik, Iceland – Full-Time
Sidekick Health
Sidekick Health is a digital health innovator founded by two doctors with a mission to improve global health. Our team of over 300 passionate and creative specialists is committed to making a positive impact, growing, and challenging ourselves—while having fun along the way!
Our offices are located in Kópavogur, Iceland, and Hamburg, Germany.
About the Role
As the QM/RA Manager, you will play a key role in advancing our mission by ensuring the implementation of quality and regulatory requirements and supporting the compliant development of our innovative software medical devices.
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Implementation of a QMS (Quality Management System), monitoring and management of the development of all processes according to MDR (Medical Device Regulation) (Regulation (EU) 2017/745).
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Ensuring the conformity of all documents and processes with all relevant regulations, guidelines and standards for the European market, in particular ISO 13485/ ISO 14971, IEC 62304/ IEC 62366, i.e.
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Ensures the activities of all departments at the site remain in compliance with the QMS
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Promoting awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
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Coordinating projects and supporting departments in meeting all quality and regulatory requirements.
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Regular conduction and monitoring of internal and external audits.
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Responsible for guiding the implementation of processes such as document control/change control and training activities i.e.
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Contact point for colleagues in the company regarding all questions regarding technical documentation and the approval of medical devices.
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Reporting to the top management about the effectiveness of the quality management system and any need for improvements.
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You have a bachelor's degree in a technical, scientific or economic field
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You have at least 3 years of relevant professional experience
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You have very good knowledge of the regulatory requirements, particularly EN ISO 13485 and the Medical Devices Regulation (EU) 2017/745
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You understand technical documentation and product and process-relevant standards (I.E.ISO 14971, IEC 62304, IEC 62366)
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You are knowledgeable regarding the approval of medical devices and the expectations of approval authorities
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You are structured, conscientious, and reliable with the ability to think and act systematically
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You are an excellent communicator (written and verbal) and have deep analytical skills
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You are solution oriented and love to solve problems
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You are have a get things down type of attitude and are able to motivate others to do the same
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You ideally have experience in using Confluence and JIRA
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You are passionate about our mission of improving the health of humanity
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You are humble, yet driven and determined
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You believe in a team-first mentality
Enska
Íslenska
