EMEA Regulatory Affairs Specialist – Clinical Investigations

Boston Scientific; Madrid; Hybrid; EUR 60.000 - 80.000; Vollzeit

Benefits dieser Stelle

Private health insurance

Life insurance

Pension plan

Restaurant tickets

Flexible work arrangements

Zusammenfassung

Boston Scientific is seeking a Regulatory Affairs Specialist for the EMEA region. The role focuses on coordinating regulatory activities for clinical investigations, preparing dossiers, and maintaining accurate regulatory files within a hybrid Madrid office environment.

You will work with Competent Authorities, ensure timely submissions, and support safety reporting and regulatory intelligence. A background in medical devices and strong English communication are essential.

Qualifikationen

• Minimum of 2 years' experience in regulatory affairs with hands-on clinical investigation submissions for medical devices.
• Working knowledge of ISO 14155, EU MDR 2017/745, MDCG 2021-6 and MDCG 2020-10/1.
• Excellent written and verbal communication in English.
• Strong organizational and analytical skills for sequential regulatory activities.
• Ability to work in a cross-functional, fast-paced environment.

Aufgaben

• Prepare, review, submit and file dossiers for clinical investigations with Competent Authorities and regulatory agencies.
• Maintain regulatory files and tracking databases.
• Prepare, submit and file communications with authorities and regulatory agencies.
• Submit required safety reporting information.
• Participate in cross-functional meetings and regulatory intelligence activities.

Kenntnisse

Regulatory affairs experience

English communication

Cross-functional collaboration

Project management

Tools

ISO 14155

EU MDR 2017/745

MDCG 2021-6

MDCG 2020-10/1

Jobbeschreibung

Boston Scientific is seeking a Regulatory Affairs Specialist for the EMEA region. The role focuses on coordinating regulatory activities for clinical investigations, preparing dossiers, and maintaining accurate regulatory files within a hybrid Madrid office environment.

You will work with Competent Authorities, ensure timely submissions, and support safety reporting and regulatory intelligence. A background in medical devices and strong English communication are essential.