Regulatory Affairs Specialist

Job Summary

To support regulatory project execution, the full-time Regulatory Affairs Specialist will manage the preparation of documents for regulatory submissions and maintain regulatory files while working remotely during CST or EST hours.

Key responsibilities:

• Support regulatory project plan execution and maintain awareness of regulatory requirements
• Compile and prepare responses to regulatory authorities' inquiries and assist in the preparation of labeling and SOPs
• Edit and proofread regulatory documentation, ensuring compliance with established standards

Required qualifications:

• Bachelor's degree in a scientific discipline
• 1-3 years of experience with US and OUS device regulations, including EU regulations
• Experience in regulatory strategy development and interaction with external regulators
• Familiarity with medical devices and related regulatory documentation
• Strong administrative and project management skills