Legal Regulatory Affairs Specialist

About the role

Fujifilm Spain is looking for a Legal Regulatory Affairs Specialist to join its Legal Department in Alcobendas. The role focuses on ensuring compliance with quality and regulatory standards for healthcare products in a highly regulated market.

Key responsibilities

• Manage and maintain compliance with quality and regulatory requirements applicable to healthcare products and services.
• Coordinate and participate in cross‑functional projects related to regulatory affairs and quality management.
• Support and lead internal and external audits, including renewal, expansion, and acquisition of certifications such as ISO standards.
• Collaborate closely with European quality teams to ensure alignment and effective communication.
• Provide legal and regulatory advice to support business operations and product lifecycle management.
• Monitor changes in relevant regulations and standards, ensuring timely implementation within the company.
• Prepare and review documentation required for regulatory submissions and certifications.

Required profile

• Degree in Law or a related field with a strong legal background.
• 4‑5 years of professional experience in legal and regulatory affairs, preferably within multinational companies in the healthcare sector.
• Proven experience and training in quality management and regulatory compliance.
• Strong project‑management skills with experience coordinating multidisciplinary projects.
• Very high level of English (C1/C2), both written and spoken.
• Experience participating in audits and managing certification processes (ISO and others).
• Excellent communication, analytical, and problem‑solving abilities.

Required skills

• ISO standards
• Regulatory compliance