Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Specialist.

Key Responsibilities

• Assist with compiling, preparing, reviewing, and submitting regulatory submissions to authorities in and outside the US
• Maintain regulatory shipping authorization documentation and prepare annual licenses and registration renewals
• Collaborate with internal teams to ensure compliance with applicable standards and interpret regulatory requirements

Required Qualifications

• Bachelor's degree and a minimum of 2 years of related experience, or an advanced degree without experience
• Working knowledge of domestic and international regulatory guidelines, policies, and regulations
• Ability to manage multiple priorities in a fast-paced environment
• Experience with pre- and post-market medical device submissions
• Proficiency in MS Word, Excel, Adobe, and PowerPoint