Full-time · Germany
Application Deadline: December 31st, 2024
QM/RA Manager
Quality Management/Regulatory Affairs Manager
Reykjavik, Iceland OR Hamburg, Germany – 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.
Responsibilities
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).
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.
Ensures the activities of all departments at the site remain in compliance with the QMS
Promoting awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
Coordinating projects and supporting departments in meeting all quality and regulatory requirements.
Regular conduction and monitoring of internal and external audits.
Responsible for guiding the implementation of processes such as document control/change control and training activities i.e.
Contact point for colleagues in the company regarding all questions regarding technical documentation and the approval of medical devices.
Reporting to the top management about the effectiveness of the quality management system and any need for improvements.
Requirements
You have a bachelor's degree in a technical, scientific, or economic field
You have at least 3 years of relevant professional experience
You have very good knowledge of the regulatory requirements, particularly EN ISO 13485 and the Medical Devices Regulation (EU) 2017/745
You understand technical documentation and product and process-relevant standards (I.E.ISO 14971, IEC 62304, IEC 62366)
You are knowledgeable regarding the approval of medical devices and the expectations of approval authorities
You are structured, conscientious, and reliable with the ability to think and act systematically
You are an excellent communicator (written and verbal) and have deep analytical skills
You are solution-oriented and love to solve problems
You have a get things down type of attitude and can motivate others to do the same
You ideally have experience in using Confluence and JIRA
You are passionate about our mission of improving the health of humanity
You are humble, yet driven and determined
You believe in a team-first mentality
So, do you care to join us?
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