Location: in our offices in Madrid, Spain, on a hybrid working schedule (3 days per week in the office + 2 days per week working from home).

About the role:
The Clinical Center of Excellence (CoE) is part of the EMEA Regulatory Affairs team and provides regulatory expertise and support for clinical investigations conducted across all divisions in EMEA. The Clinical CoE also drives regulatory intelligence by monitoring and ensuring timely assessment of evolving Competent Authority expectations and translating requirements into practical, scalable processes for conducting clinical investigations in EMEA.

The Regulatory Affairs Specialist is responsible for coordinating and executing assigned regulatory activities throughout the lifecycle of clinical investigations. This includes preparing and submitting Competent Authority submission and notification dossiers, responding to Competent Authority questions, submitting required safety reports, maintaining regulatory files and tracking systems, and completing ongoing regulatory maintenance activities.

In this role,



you will work cross-functionally to help ensure submission and notification quality, regulatory compliance, timely delivery, and accurate documentation across assigned clinical investi gations.

In this role, you will be responsible to:
- Prepare, review, submit and file application dossiers for clinical investigations with Competent Authorities and regulatory agencies.
- Maintain accurate and up-to-date regulatory files and tracking databases as required.
- Prepare, submit and file communications with Competent Authorities and regulatory agencies as needed, including responses to follow-up questions.
- Prepare, submit and file required safety reporting information with Competent Authorities and regulatory agencies.
- Participate in cross-functional meetings related to clinical investigations.
- Participate in regulatory intelligence monitoring and assessment activities.

What are we looking for in you:
- Min

📌 Regulatory Affairs Specialist, EMEA (España)
🏢 Boston Scientific
📍 España