Regulatory Affairs Specialist

Our client, a global healthcare organization is recruiting for Regulatory Affairs Specialists to join their team. Reporting to the Regulatory Affairs Manager, your duties would include;

• Creating and reviewing regulatory documentation for Drug, Device and Combination product renewals with major focus on Medical Device renewals.
• Interacting with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals.
• Tracking status and progress of regulatory documentation that will be used for renewals.
• Coordinating and compiling responses to regulatory authority renewal questions (under supervision)
• Using an electronic document management system to compile documents to support product renewals for submission to Health Authorities
• Answering internal queries for assigned products.
• Maintaining Database of Regulatory Requirements for renewals

• Regulatory experience within a healthcare environment, specifically Medical Devices
• Administrative and project management skills
• Ability to contribute to multiple projects from a regulatory affair perspective
• Technical system skills (e.g. word processing, excel, SmartSheet, databases, online research)
• Ability to independently identify compliance risks and resolve or escalate as necessary
• Ability to multitask and prioritize
• Based Locally

• Bachelor’s degree or country equivalent in a relevant scientific discipline