Regulatory & Start-up Manager, Iqvia Medtech, Portugal & Spain

IQVIA UK

Portugal
Homebased
Eu ctr regulatory submission experience
Spanish language proficiency for authorities
Medical device regulatory landscape knowledge
IQVIA UK is seeking a Regulatory & Start-up Manager for their Medtech division in Portugal and Spain to oversee site activation, regulatory activities, and project management for clinical studies. The ideal candidate should possess a strong background in regulatory submissions, particularly in the medical device sector, and must be proficient in Spanish

Job Summary

  • The role involves directing and managing the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs.
  • Candidates must possess proven experience in Regulatory Submissions for Medical Devices and specific EU CTR experience essential for compliance.
  • The position requires Spanish language proficiency for direct communication with Competent Authorities and Ethics Committees in Portugal and Spain.

Matching Summary

Match Score: 85

IQVIA UK is seeking a Regulatory & Start-up Manager for their Medtech division in Portugal and Spain to oversee site activation, regulatory activities, and project management for clinical studies. The ideal candidate should possess a strong background in regulatory submissions, particularly in the medical device sector, and must be proficient in Spanish.

Skills & Requirements

Must-have

  • EU CTR regulatory submission experience
  • Spanish language proficiency for authorities
  • Medical device regulatory landscape knowledge
  • Site activation and maintenance oversight
  • Multi-regional clinical trial management

Nice-to-have

  • Strong negotiation and communication skills
  • Ability to mentor and coach colleagues
  • Experience with bid defense activities
  • Proficiency in CTMS and tracking tools
  • Creative problem solving for regulatory challenges

Key Requirements

  • Bachelor's Degree in Life Sciences
  • 5-7 years relevant scientific or clinical experience
  • Proven experience in global regulatory roles
  • Must have Spanish language proficiency

Work Rights

Not specified

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