Remote Regulatory Affairs Specialist

Job Summary

To support global regulatory projects, the Remote Regulatory Affairs Specialist will coordinate submissions and ensure compliance for medical devices in international markets while working remotely on a contract basis.

Key responsibilities

• Support the execution of global regulatory project plans and maintain compliant regulatory files
• Review, evaluate, edit, and proofread technical and scientific data, reports, and departmental SOPs
• Participate as an active regulatory member on cross-functional project teams to support strategy alignment

Required qualifications

• Bachelor's degree in a relevant scientific discipline (or country equivalent)
• Knowledge of basic scientific principles and regulatory concepts
• Strong technical system skills (word processing, spreadsheets, databases, online research)
• Proven administrative, task prioritization, and project management skills
• Familiarity with USA (FDA) and OUS medical device regulations (specifically EU MDR/device regulations) is preferred