Application Deadline: December 15th, 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?