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Medical Device Lead

hace 2 meses

Guadalajara, Guadalajara, España Importante empresa A tiempo completo
Job Description

**About the Role**

We are seeking a highly skilled and experienced Medical Device Lead to join our team at Importante Empresa. As a key member of our Innovative Medicine department, you will play a critical role in supporting the development and implementation of our medical device strategies.

Key Responsibilities:

  1. Strategic Leadership: Provide strategic guidance and leadership to the IPV Team in all aspects of medical device vigilance and compliance.
  2. Compliance Operations: Ensure consistent compliance and operations approach across regions in alignment with Global Medical Safety processes.
  3. Subject Matter Expertise: Develop and maintain expertise in medical device legislation and regulations, providing guidance to Local Medical Safety Teams as needed.
  4. Collaboration and Communication: Work closely with internal and external partners to lead or participate in global or regional multi-disciplinary projects and shape strategies.
  5. Process Improvement: Identify opportunities for process improvement and influence efficiency and compliance across IPV.
  6. Audit Readiness: Support audit readiness and inspections for medical device-related activities.
  7. Regulatory Compliance: Collaborate with Regional Heads and Local Safety Officers to ensure regulatory compliance for medical device portfolio.
  8. Documentation and Translation: Document compliance processes and translate medical device requirements into regional/global IPV processes.
  9. Legislation SME: Act as medical device legislation SME for regional/global impact in IPV.
  10. Project Leadership: Lead or participate in global/regional medical device projects and shape strategies.

Requirements:

  • Proven experience in medical device vigilance and compliance.
  • Strong leadership and strategic skills.
  • Excellent communication and collaboration skills.
  • Ability to work in a hybrid model.

What We Offer:

  • A dynamic and innovative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.