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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