Regulatory Affairs Specialist - Medical Devices

Learn About knok At knok, we dare to lead and humanise the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it, and you can recognise it in every person who embraces this mission. Through a Digital Front Door strategy, knok connects patients, providers and healthcare professionals in one place. Our API-first white-label platform enables a continuous, engaging and personalised healthcare experience for all conditions through a cutting-edge Patient Journey Engine. With regular clinical practice as our main source of knowledge, we leverage ready-to-use data to improve care automation and increase financial savings. Since 2015, we have enabled more than 2.5 million clinical interactions in over 12 countries. Our platform is scalable and AI-ready, enhancing the power of data-driven care to deliver better outcomes during all stages of life. Are you ready to join us in revolutionising healthcare and making a tangible impact on people's lives? Responsibilities Manage and support regulatory processes for medical devices (primarily within the EU - MDR); Prepare technical documentation for certification (CE marking); Ensure compliance with applicable regulatory requirements; Collaborate with internal teams (product, engineering, clinical) to ensure regulatory alignment; Support and maintain the Quality Management System (QMS), ensuring compliance with standards such as ISO 13485; Liaise with notified bodies and other regulatory authorities; Monitor regulatory changes and ensure internal implementation. Requirements 3 to 5 years of experience in regulatory affairs for medical devices; Proven experience in certification processes (e.g. CE marking under MDR); Solid knowledge of quality management systems (e.g. ISO 13485); Experience in preparing technical documentation (Technical File / Design Dossier); Ability to work both independently and within a multidisciplinary team; Fluency in Portuguese and English (mandatory). Nice to Have Experience with Software as a Medical Device (SaMD); Knowledge of IEC 62304, IEC 62366 or ISO 14971; Experience with regulatory audits and inspections; Experience in digital health / health tech environment.