Regulatory Affairs Specialist

Main Job Tasks and Responsibilities:

• Coordinate and prepare document packages for regulatory submissions (domestic and international)
• Facilitate corrective actions for internal audits
• Assist during governmental inspections and support related documentation
• Coordinate activities related to recalls and medical device reports
• Prepare documentation for clinical trials in compliance with applicable regulations
• Maintain and update company policies and procedures as required
• Interact, as directed, with various levels of management, external agencies, and companies
• Participate actively on project task teams
• Perform other related duties and tasks as assigned

Education and Experience:

• Bachelor's degree and two years of related experience, or six years of regulatory experience
• Demonstrated knowledge of regulatory affairs
• Proficiency in relevant computer applications such as spreadsheets, word processing, and database tools
• Strong organizational skills, self-motivation, and attention to detail