INTRNATL REGULATORY SPECIALIST

Globus Medical is seeking an International Regulatory Specialist to manage product registrations and submissions with international regulatory agencies. This role involves collaborating with various departments to ensure product compliance with global regulations and obtain marketing clearance. The ideal candidate will have experience in medical device regulatory affairs and a strong understanding of international requirements.

• Draft, submit, and gain approval for international product registrations
• Develop submissions in conjunction with cross-functional teams
• Work with ISO, CE, FDA, and other international/local regulations
• Provide regulatory oversight for manufacturing changes
• Coordinate and review product labeling for international markets
• Maintain approved regulatory files and prepare amendments