Regulatory & Start-up Manager, Iqvia Medtech, Portugal & Spain
IQVIA
Lisbon, Portugal
Regulatory submissions for medical devices
Eu ctr experience
Spanish language proficiency
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs
Job Summary
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs.
Oversee the execution of Site Activation and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.
Matching Summary
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs.
Skills & Requirements
Must-have
Regulatory submissions for Medical Devices
EU CTR experience
Spanish language proficiency
Site activation strategy
Clinical trial environment understanding
Nice-to-have
Develop long standing customer relationships
Deliver presentations/training
Motivate, coach and mentor
Creative and practical solutions
Key Requirements
Bachelor's Degree Life sciences or related field
5 - 7 years’ relevant experience
Demonstrable experience in a global role
Proven experience in Regulatory Submissions
Strong negotiation and communication skills
Proven ability to work through others
Thorough understanding of regulated clinical trial environment
Good leadership skills
Good organizational and planning skills
Ability to exercise independent judgment
Good presentation skills
Proven ability to establish and maintain effective working relationships
Excellent understanding of study financial management