Regulatory and Start Up Manager - Medical Devices - Home- based in Spain

Job Title : Regulatory and Start Up Manager - Medical Devices - Home-based in Spain

Join PharmiWeb.jobs : Global Life Science Jobs as a Regulatory and Start Up Manager, responsible for overseeing site activation, maintenance, and regulatory activities for medical device studies in Spain. This role requires experience with medical device submissions (MD / IVD), site activation oversight, and fluency in Spanish.

Key Responsibilities :

• Manage site activation, including pre-award activities, ensuring adherence to project timelines.
• Develop and implement management plans aligned with project scope and strategy.
• Coordinate with regional teams to ensure successful project delivery and compliance.
• Prepare and review technical and administrative documentation for study initiation and maintenance.
• Provide regulatory and scientific support to facilitate clinical trial processes.
• Guide multi-regional programs during start-up and maintenance phases.
• Determine regulatory strategies and manage submissions and authorizations.
• Assess regulatory landscape and provide intelligence to support studies.
• Ensure quality standards and maintain internal systems and databases.
• Build relationships with clients and deliver presentations or training as needed.
• Participate in budget planning and reviews.

Qualifications :

IQVIA is committed to diversity and inclusion, fostering a culture of belonging and innovation.

Additional Details :

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