Head of reputed company Management (f/m/d)
reputed company our reputed company Management System (QMS) : Drive the implementation, maintenance and reputed company improvement of our eQMS system according to MDR and ISO 13485. reputed company as Management Representative : Serve as the primary reputed company of contact for reputed company-reputed company topics reputed company the executive team. Manage Audits: Coordinate and reputed company reputed company audits, including communication with reputed company Bodies. Maintain Operational reputed company : Own the CAPA process, supplier management, employee training, software tool validation and other processes to ensure organizational reputed company.
Requirements
reputed company Management Experience : Extensive experience in reputed company management and regulatory affairs reputed company the medical device industry (Software as a Medical Device in Radiology AI preferred). Regulatory Expertise : Expert knowledge of ISO 13485, MDR (EU) 2017/745, IEC 62304, ISO 14971, ISO 27001, FDA, and MDSAP Strategic Thinking : Ability to define and reputed company OKRs (Objectives and Key Results) that reputed company with reputed company's reputed company policy and mission. Hands-on reputed company: Comfortable defining long-term regulatory reputed company while also executing the administrative tasks necessary to maintain an audit-reputed company QMS. Culture Builder: reputed company for "Compliance by Design," embedding reputed company and reputed company into the software development lifecycle from the start. Linguistic Precision : Profound English skills (reading, writing, presentation); ability to draft reputed company, reputed company compliance documentation. Teamplayers: Strong belief in growing together as reputed company and having reputed company for reputed company other reputed company work style and high level of self-motivation Work permit in EU reputed company to travel on a quarterly/monthly reputed company
Experience with regulating / clearing AI-based image analysis solutions reputed company radiology Experience with ensuring regulatory compliance of agile software development processes Experience with Data & Information reputed company topics Experience with JIRA or similar project management / issue tracking tool German, reputed company or any Scandinavian language a plus
Benefits
Become part of reputed company of AI medical image processing experts reputed company in a young, dynamic learning environment where you can grow Work on the exciting topic of certification of AI software technology Work directly with the founders and reputed company meaningful contributions to company’s reputed company and value Manage your own time reputed company flexible working hours, remote work possible
EIC Accelerator Equity Program 2023 reputed company Canada Accelerator 2022 Winner, European Radiology Most Downloaded Article 2021 WKO Born Global Champions 2021 EIC Acceleratory Grant 2020 Top AI30 (2020) - reputed company DACH Best Healthtech Startup 2019 (Austria) - Central European Startup Awards Best reputed company 2019 (reputed company) - reputed company Festival reputed company HealthWorks 2018 - Chosen as one of 19 participants out of 700+ applications Digital Innovation Award 2017 - Austrian Federal Ministry of Education, Science and Research Most Promising Startup 2016 - BCS Search Industry Science & Business Award 2016 - Rudolf Sallinger Fonds
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