Regulatory Affairs Specialist

Job Summary

Supporting global regulatory operations, the contract Regulatory Affairs Specialist in medical devices will compile technical documentation for submissions, collaborate with cross-functional teams, and assist in preparing responses to regulatory authorities, all while working remotely.

Key responsibilities

• Compile, track, and organize technical documentation for global regulatory submissions
• Collaborate with cross-functional team members to gather scientific data and ensure project alignment
• Edit and proofread labeling, SOPs, and departmental technical documentation

Required qualifications

• Bachelor's degree in a scientific discipline or equivalent field (non-scientific degrees accepted with relevant coursework/training)
• Strong problem-solving, project management, and multitasking abilities
• Excellent interpersonal and communication skills for cross-functional collaboration
• Proficiency in technical computer applications (spreadsheets, databases, word processing)