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 integral medical device environment.

Compensaciones / Beneficios
• 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)
🏢 Boston Scientific
📍 Madrid