Quality Assurance & Regulatory Affairs Specialist

About the role

Fujifilm Spain is looking for a Quality Assurance & Regulatory Affairs Specialist to join its Legal Department in Alcobendas. The role focuses on ensuring that healthcare products and services meet all applicable quality and regulatory standards in a highly regulated market.

Key responsibilities

• Manage and maintain compliance with quality and regulatory requirements for 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 and ensure timely implementation.
• Prepare and review documentation required for regulatory submissions and certifications.

Required profile

• Degree in Law, Pharmacy, Chemistry, Environmental Sciences or a related field.
• 3‑5 years of professional experience in 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 in multidisciplinary projects.
• Very high level of English (C1/C2) – written and spoken.

Required skills

• ISO 9001
• ISO 14001
• ISO 13485
• MDR (Medical Device Regulation)