Remoto: Teletrabajo
Job Title: Quality & Regulatory Affairs Specialist (QA/RA Specialist)Location: Remote, EU citizenship required (European time zones a must)Role Description:Join a fast-growing MedTech startup on a mission to make medical device compliance faster and easier. As a Quality & Regulatory Affairs Specialist, you’ll work hands-on to prepare regulatory submissions, create quality and technical documentation, support clients, and contribute to the development of innovative AI-powered compliance tools.Sector: Medical Devices, MedTech, AI-driven Regulatory SolutionsMust-Have Skills and Experience:Bachelor’s degree in Engineering, Life Sciences, or related field2–4 years’ experience in regulatory or clinical affairs within medical devicesHands-on experience preparing technical documentation for EU regulatory submissionsSolid knowledge of EU MDR (2017/745) and medical device standards (ISO 13485, ISO 14971, IEC 62304)Strong client-facing and communication skillsAbility to work in a fast-paced, dynamic environment (startup experience preferred)Collaborate with cross-functional teams including engineering and product developmentMonitor general regulatory changes and adapt processes accordinglyDesirable Skills and Experience:Familiarity with US FDA regulations, 510(k), PMA, De Novo, and Q-SubmissionsExperience with Software as a Medical Device (SaMD) and hardware devicesKnowledge of broader quality systems (CAPA, post-market surveillance)Experience with AI tools or prompt engineering with LLMsFamiliarity with Notified Body conformity assessments and auditsWhat We Offer:Fully remote work with flexible hoursOpportunity to work at the forefront of MedTech and AI compliance innovationHow to Apply:Apply directly on LinkedIn. Interviews are moving fast and can be scheduled within a week, so early applications are strongly encouraged.#J-18808-Ljbffr