Regulatory Affairs Specialist

Job Summary

Seeking a proactive Regulatory Affairs Specialist for a remote contract position in the medical device sector, who will manage global regulatory documentation, prepare submissions for regulatory bodies, and collaborate with cross-functional teams to support international project plans.

Key responsibilities

• Coordinate and prepare global regulatory documentation, submissions, and responses for external regulatory bodies
• Review, edit, and proofread scientific data, technical reports, product labeling, and SOPs for compliance
• Maintain organized regulatory files and track document progress across multiple project streams

Required qualifications

• Bachelor's degree in a relevant scientific or related technical discipline
• Proven problem-solving capabilities and ability to work autonomously
• Excellent project management and organizational skills
• Proficiency with technical office systems and document databases