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FDA Compliance Project Leader

Il y a 3 mois

Lille, Hauts-de-France Meent Life Sciences Temps plein

Position Title: FDA Compliance Project Leader
Organization: MEENT Life Sciences

MEENT Life Sciences stands at the forefront of the life sciences industry, delivering exceptional expertise in engineering consultancy and clinical research. Our dedication to innovation and excellence empowers us to offer tailored solutions that meet the intricate demands of our clients in the healthcare domain.

Role Overview:
  • Management of projects aimed at achieving FDA compliance
  • Oversight of project activities including scheduling, financial planning, risk assessment, and monitoring of action plans
  • Facilitating the process of bringing Medical Devices to FDA compliance
Candidate Profile:
  • Comprehensive knowledge of US regulatory frameworks (510K, FDA) pertaining to medical devices and pharmaceutical registration
  • Proven experience within the healthcare industry, specifically with Medical Devices and pharmaceuticals
  • Awareness of US cultural nuances is advantageous
  • Proficiency in both English and French languages