Head of QARA Department

You are passionate about Quality Assurance applied to medical devicesYou have at least four years of professional experience in regulatory affairs or quality management systems relating to medical devicesYou have an experience of medical device standards and regulations, especially applied to software:ISO 13485ISO 14971IEC 62304, IEC 62366US regulations: 21 CFR Part 820 Quality System RegulationsKnowledge and experience of EU medical device regulation (MDR)Show us you are the best candidateYOU WONDER WHO WE ARE?Therapixel is one of the leading French software companies specializing in artificial intelligence applied to medical imaging. Our goal is to provide radiologists with innovative software, designed with a high level of safety, quality, and performance, to help them improve their clinical practice. We are a multicultural, dynamic, and dedicated team. We create an energizing work environment driven by talented people who share the same vision and passion. We truly encourage diversity and gender inclusive work environment. Our strong sense of mutual commitment creates synergy pushing away all medical imaging limits. We develop technology for goodAre you ready to join us?ABOUT THE POSITIONThe QARA Department oversees the management systems for Therapixel. The Head of QARA Department define the regulatory strategy for Therapixel products in collaboration with top management and continuously monitors and communicates regulatory changes that impact Therapixel. The Head of QARA is responsible for Therapixel’s compliance with applicable quality standards and medical device regulation.As our Head of QARA Department your Missions and Responsibilities, will be:Overall responsibility for developing, implementing and maintaining the Therapixel Management Systems.Applying, maintaining, monitoring, and adapting the policies of TherapixelOrganizing management reviews, internal and external auditsCreating and assessing non-conformities in response to problems detected from sources such as customer complaints, device problems, supplier problems etc.Creating Corrective and Preventive Actions (CAPA) and monitoring progress.Managing and controlling changes made to the Management Systems.Coordinating Field-Safety Corrective Actions.Gathering post-market dataKeeping technical files updated.Liaison with Notified Bodies, Certification Bodies and Competent Authorities for device registration, certifications and updates.Review of applicable regulations and ensuring Therapixel is compliant.In collaboration with top management, defines Therapixel’s regulatory strategy.Ensure Therapixel products are developed and marketed according to regulations.Maintains up-to-date his/her knowledge of standards and regulations and anticipates regulatory changes.Foster a Quality culture within Therapixel through communication of policies and training to staff.Work with the Data Privacy Officer (DPO) and SysAdmin to implement the information security policy.Communicating with competent authorities on matters of medical device vigilance.Ensuring the conformity of the device in accordance with the quality management system under which the devices are manufactured, before a device is released.Fulfilling the reporting obligations referred to in the European Medical Device RegulationIt’s necessary to have:Scientific Degree, biomedical engineering preferredAt least four years of professional experience in regulatory affairs and quality management systems relating to medical devices, Software as a Medical Device (SaaMD) preferredKnowledge and experience of medical device standards and regulations, especially applied to software: ISO 13485, ISO 14971, IEC 62304, IEC 62366, US regulations: 21 CFR Part 820 Quality System RegulationsKnowledge and experience of EU medical device regulation (MDR)Additionally, knowledge of information security standards and regulations would be appreciated: ISO 27001, ISO 27018, Applicable FDA guidance on cybersecurity applied to medical devices, including ANSI UL 2900-2-1, HIPAA and GDPRSome essentials you need to have:Proven ability to conduct regulatory submissions to the FDA.Good organizational and planning skills.Ability to write clear and effective procedures.Proficiency with MS Office (Word, Excel, Powerpoint)English and French language to professional working level.This is an exciting opportunity if you are:Self-starter, autonomous, hands-on, pro-active, with can-do attitude.Low ego, collaborative, initiatives taking but not in isolation.High accountability, ownership, no “not-my-job”.What Therapixel’s team expect from you:Thrive for excellence.Creative, curious, and ingenuous.Our working conditions….A convivial and flexible working environment, with a remote culture.Supportive environment (hiring, retaining, and promoting women is an integral part of our company’s culture).A company culture based on autonomy & accountabilityLunch card Swile, participation in your work-to-home travel expenses, sport membership participation, 100% coverage of the health insurance for you and your family.Annual company seminars to discover beautiful places and make strong connections.Offsites, after-work drinks, celebration of our success to recharge, have some fun and build shared memories and a strong team.International working environnementLocation: Hybrid: our Paris office + remoteContract: permanentHere are the stages in our recruitment process:Discussions about your driving forces, your ambitions and our mindsetTechnical testsDiscussions with one or more members of the team, including your future managerDiscussions with our CEO or Chief People OfficerOur recruitment process is mainly conducted by videoconference.We are an equal opportunity employer and are committed to creating a diverse and inclusive workplace. We are proud to foster a workplace free from discrimination. We encourage all qualified individuals to apply.PLEASE SEND YOUR CV AND A COVERING LETTER TO JOBS@THERAPIXEL.COM OR APPLY ↓ #J-18808-Ljbffr