Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist (Technical Person – Spain)

Location: Spain
Employment Type: 1 years FTC

Role Overview

We are seeking a Regulatory Affairs Specialist (Technical Person) to support local regulatory activities in Spain. This role will act as the key point of contact with Health Authorities and ensure compliance with local regulatory requirements.

Due to regulatory requirements, candidates must hold a degree in Pharmacy, Biology, or Medicine obtained from a Spanish institution.

Key Responsibilities

• Manage and maintain the local Health Authority (HA) database, including accurate product entries and updates
• Act as the primary contact for local Health Authorities and external bodies (e.g., customs authorities)
• Oversee product registrations, notifications, and lifecycle management
• Manage licenses, including importation licenses and related regulatory approvals
• Support general regulatory affairs activities across local and global systems
• Collect and prepare regulatory documentation (e.g., Declarations of Conformity, labels, IFUs) for submissions and notifications
• Ensure compliance with local regulatory requirements and internal processes

Key Requirements

• Degree in Pharmacy, Biology, or Medicine from a Spanish university
• Previous experience in Regulatory Affairs, ideally within medical devices, pharmaceuticals, or healthcare
• Familiarity with Health Authority interactions and regulatory submissions
• Strong attention to detail and ability to manage documentation accurately
• Ability to work cross-functionally and communicate effectively with internal and external stakeholders
• Fluent in Spanish and English

Preferred Skills

• Experience working with local and global regulatory systems
• Knowledge of product registration and licensing processes in Spain
• Understanding of compliance requirements within healthcare or life sciences

Why Join Us

• Opportunity to work closely with Health Authorities and regulatory processes
• Exposure to both local and global regulatory environments
• Collaborative and dynamic team environment