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 general 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 activitiesResponsabilidades




- 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 environmentRequisitos 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