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

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Home Based role requiring submissions experience with MD/IVD and Spanish language fluency.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
• Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications
Bachelor’s Degree in life sciences or a related field and 2 years plus clinical research or other relevant experience in submissions.
In-depth knowledge of clinical systems, procedures, and corporate standards.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.