Experteer Overview In this role you support regulatory activities for clinical investigations across EMEA, ensuring compliant submissions and timely interactions with Competent Authorities. You will work with cross-functional teams to maintain regulatory files, monitor evolving requirements, and translate regulatory expectations into scalable processes. This position is a hands‑on, fast‑paced opportunity to shape how clinical investigations are conducted within a global medical device environment. Compensaciones / Incentivos * Prepare, review, submit and file dossiers for clinical investigations with Competent Authorities and regulatory agencies * Maintain accurate regulatory files and tracking databases * Prepare, submit and file communications with authorities, including follow‑up responses * Submit required safety reporting information to authorities * Participate in cross‑functional meetings related to clinical investigations * Participate in regulatory intelligence monitoring and assessment activities Responsabilidades * Minimum of 2 years' experience in regulatory affairs,



including hands‑on submissions for clinical investigations in medical devices * Working knowledge of ISO 14155, EU MDR 2017/745, MDCG 2021-6 and MDCG 2020-10/1 and related regulations * Excellent written and verbal communication skills in English * Strong organizational and analytical skills; ability to manage sequential regulatory activities and prioritize * Resilience and solution‑focused mindset in a fast‑paced clinical environment * Ability to work effectively in a cross‑functional, collaborative environment * Nice‑to‑have project management experience in a regulated environment Requisitos principales * Private Health and Life Insurance * Attractive Pension plan * Ticket Restaurants * Healthy work‑life balance with flexibility * International environment with diverse colleagues * Career Development opportunities Regulatory Affairs Specialist, EMEA Madrid, ES #J-18808-Ljbffr

📌 Regulatory Affairs Specialist, Emea (Madrid)
🏢 Boston Scientific
📍 Madrid