Regulatory Affairs Associate Consultant

Added
1 hour ago
Type
Contract
Salary
Salary not provided

Related skills

documentation regulatory affairs medical devices pharmaceuticals regulatory submissions

📋 Description

  • Support regulatory submissions and license maintenance for medical devices and pharma in GCC.
  • Develop and execute regulatory plans for new products and for existing licenses.
  • Handle regulatory responsibilities in GCC markets and join cross-functional teams.
  • Monitor regulatory requirements; ensure compliance with Baxter standards.
  • Submit safety and labeling updates to local Health Authorities.
  • Maintain Baxter RA data and TrackWise/SharePoint systems.

🎯 Requirements

  • Bachelor’s degree in Pharmacy, Biomedical Engineering or related field; 1-5 years RA in medical devices.
  • Hands-on experience preparing regulatory submissions for development and marketing authorizations.
  • Excellent written and verbal communication and presentation skills.
  • Strong interpersonal and negotiation skills.
  • Ability to identify compliance risks and escalate when necessary.
  • Ability to manage multiple projects in a matrix, timeline-driven environment.

🎁 Benefits

  • Direct sponsor exposure with CRO support—best of both worlds.
  • Global client-facing role with professional development.
  • Quality-focused environment with supportive culture.
  • Collaborative, multicultural teams.
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