Regulatory/Quality Manager
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Noord-Holland Netherlands.
As QA/RA Manager you are responsible for the quality assurance and regulatory affairs strategy at a fast-growing medical device start-up. This concretely means further setting up a quality management system (ISO 13485), defining a regulatory strategy concerning MDR (Medical Device Regulation), succesfully submitting the FDA documentations that are required to operate in America and managing product registrations (such as CE marking). You will be responsible for the creation, documentation and maintenance of the (software) Technical Documentation for our medical devices.
- Prepare and submid FDA documentation
- Train colleagues how to be and stay compliant
- Internal and external audits
- Maintain the QMS, in order to stay compliant with the applicable European laws and standards.
- Implement Change management and Risk Management
- Have experience with implementing a QMS from Zero
- Experience with Medical Requirements ISO 13485 and preferably IEC 62304
- Strong communicator and able to show the company what way to take in terms of QA and RA
- Entusiasm to make a difference in the Medical World and help prevent Skin Cancer all over the world.
The Company
They are a fast growing medical company focused on solving Skin Cancer casualties. They want to achieve this by bringing the dermatologist closer to you. Many patients were/are not aware of the risks and problems of Skin Cancer. Naturaly we do not know how to asses our skin for Cancer before you have actually been in contact with the problem. To prevent being 'too late' they desinged software for your phone where every picture you take will be assessed by the software behind it. The company is now looking for a strong QA/RA Manager to lead and manage the process to certification for ISO 13485 and the FDA.Role Description
You will be responsible for the implementation of the QMS ISO 13485 and the submission of FDA requirements. You will have a responsible and independent role to support the company towards a succerful implementation of unique and life-saving Medical software.As QA/RA Manager you are responsible for the quality assurance and regulatory affairs strategy at a fast-growing medical device start-up. This concretely means further setting up a quality management system (ISO 13485), defining a regulatory strategy concerning MDR (Medical Device Regulation), succesfully submitting the FDA documentations that are required to operate in America and managing product registrations (such as CE marking). You will be responsible for the creation, documentation and maintenance of the (software) Technical Documentation for our medical devices.
Responsibilities
- Assure the implementation of the ISO 13485- Prepare and submid FDA documentation
- Train colleagues how to be and stay compliant
- Internal and external audits
- Maintain the QMS, in order to stay compliant with the applicable European laws and standards.
- Implement Change management and Risk Management
Requirements
- At least 5 years of experience in QA and RA- Have experience with implementing a QMS from Zero
- Experience with Medical Requirements ISO 13485 and preferably IEC 62304
- Strong communicator and able to show the company what way to take in terms of QA and RA
- Entusiasm to make a difference in the Medical World and help prevent Skin Cancer all over the world.
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