CRO Operations Manager – Clinical & Regulatory

About the role

Iberania, a European full‑service Medical Device CRO, is looking for a CRO Operations Manager to join its Madrid office. This full‑time, on‑site position will lead clinical, regulatory and scientific operations, ensuring projects meet timelines, quality standards and client expectations.

Key responsibilities

• Oversee day‑to‑day clinical operations, regulatory submissions and scientific project delivery.
• Coordinate cross‑functional teams to align project plans, budgets and resources.
• Monitor project performance, identify risks and implement corrective actions.
• Ensure compliance with ISO standards, MDR and other applicable regulations.
• Maintain high levels of client satisfaction through proactive communication.
• Develop and execute strategic initiatives to improve productivity and quality.

Required profile

• Extensive experience in Clinical Operations, Project Management and Regulatory Compliance within the medical device sector.
• Strong ability to coordinate teams, communicate clearly and resolve conflicts.
• Bachelor’s degree in Life Sciences, Medicine, Health Management or related field; advanced degrees are a plus.
• Fluency in English; Spanish proficiency highly advantageous.
• Willingness to work on‑site in Madrid and travel as needed.

Required skills

• Knowledge of ISO standards and MDR regulations.
• Proficiency with project monitoring, budgeting and reporting tools.
• Experience using regulatory compliance software.