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 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