QUALITY & REGULATORY MANAGER (ISO 13485)

About us 🩺Legit.Health deploys computer vision and artificial intelligence technology to enable lifesaving diagnosis and therapies for visible diseases. Our goal is to enable universal access to high-quality diagnosis and follow-up of pathologies and to offer affordable health assistance to everyone everywhere.Things you should know before following and signing up for the position:We are a startup, it is important that you are knowledgeable about how startups operate and know that at this stage there are more unknowns than certainties. There are many things to discover and define yet, so you will be part of that definition, therefore you will have many functions helping the management.At Legit.Health we have a friendly open collaborative culture and a united team vision. We love entrepreneurial/risk taking/high ambition mindsets. Our work is rewarding and we help each other win by creating a supportive and collaborative environment for one another. Take a look at our opening below and send us your application - we look forward to hearing from you!Job description 🧑‍💻The Quality and Regulatory Manager plays an integral role in ensuring that quality standards are met throughout our processes. They ensure that the product meets the customer's expectations and complies with all relevant regulations, specially ISO 13485, IEC 62304 and ISO 14971. They also ensure that the company has adequate resources to meet its obligations.The primary responsibility of the Quality and Regulatory Manager is to oversee the implementation of quality control procedures at each stage of development or commercialization. What you need to achieve 💪🏻Ensure compliance with the standards of quality ISO 13485 and Regulation (EU) 2017/745 for software as medical devices.Establish strong and collaborative relationships with key internal stakeholders, digital health professionals, and industry peers, notified bodies and competent authorities if applicable.Analyze and process quality problems, development, implementation, and follow-up of corrective measures. Propose and document risk minimization in conjunction with the Digital Solution Owner, Medical Affairs, Usability Validation Scientist, and Cybersecurity expert as the main stakeholdersContinuous improvement and maintenance of the integrated Quality Management System.Ensure a high degree of audit readiness to minimize the risk of audit observations and be responsible for external quality audits by clients or other bodies.Be responsible to provide input, define procedures, lead improvement initiatives to the technical elements of the QMS as the subject matter expert in software development and be responsible for ensuring instructional quality documents (QAPs, SOPs, WIs, templates, checklists).Provide training to the people in the scope of the QMS on the applicable procedures and/or standards.To compile, analyze and evaluate the non-conformities.To identify, keep records, segregate and manage non-conforming products and control non-conformities and their corrective and preventive actions.To collect records to guarantee the traceability of the products developed.To notify and design the internal audit programme.To manage the records of internal and external audits.To monitor the actions implemented as a result of the audits.To guarantee the general safety and performance requirements compliance and the performance and documentation of the tests that are applicable to the company's medical device.Before releasing a product, to check its conformity properly through the quality management system used by the company.To guarantee the existence and up-to-date status of the technical documentation and the EU declaration of product conformity.To ensure that post-marketing monitoring obligations are met.Person Responsible for Regulatory Compliance (PRRC).Must have 🔍 Prior experience in similar positions in the healthcare industry.Prior experience with medical device regulations in the EU and USA, specially in relation to software as medical device.Knowledge of ISO 13485 and/or ISO 14971.Advanced spoken and written English (C1 level).Expertise with task management softwares such as JIRA, Asana or similar is a plus.Knowledge of AI, machine learning and software development is a plus.Analytical, ability to communicate, disciplined, highly organized, proactive and adaptable.Experience handling highly sensitive and confidential information.Legal permission to work in Spain. Important 🙌🏼Able to work autonomously, with discipline and with high motivation and energyProactive, willing to learn, have an impact and grow in the company Team player capable of adapting to changes in a fast-paced environmentWhat do we offer 🏝️Full-remote position. We are a team of committed professionals, so you choose where you work from and also means that all processes need to be thought of as if we had no office and everyone is working remotely. No one will feel like an outsider, since all conversation will need to happen on slack or hangouts.Working in a fast growing Start-up environment within an international contextFlexible compensation (Cobee): daycare and restaurantFlexible vacation policy: 23 working days per year + 2 additional days granted by the company (your birthday and December 7th) + 2 days for company closure per labor agreement (December 24th and 31st)Flexible working hoursPart time contractStarting day: as soon as possible.Competitive salary according to your experienceLanguages 🌍High Spanish and English proficiency (writing and speaking).Additional European languages are a plusAdditional languages are welcome.In compliance with the provisions of the data protection regulations, we inform you that the personal data you have provided with your resume will be processed in a mixed manner (automated or not) by AI Labs Group, S.L., with NIF B95988127 and address in Gran Vía, 1, BAT Tower, Bilbao (Bizkaia), 48001  (hereinafter, Legit.Health).The purpose of this data processing is the management of Legit.Health's personnel selection processes and is based on your prior consent. Your data will be kept for one year, after which we will proceed to cancel it. You are also informed that no automated decisions will be made.Your data will not be transferred to third parties. At any time you can exercise your rights of access, rectification, deletion, portability, limitation, or opposition, by writing to the email gdpr@legit.health. We also inform you that you can go to the Control Authority to assert your data protection rights.Sincerely, Legit.Health team.