REGULATORY AFFAIRS ASSOCIATE

JOB PURPOSE

The Regulatory Affairs Associate is responsible for the testing of new products to support regulatory clearance activities.

KEY DUTIES & RESPONSIBILITIES

• Perform new product validation studies that are required for Design History Files and submissions to national and international regulatory bodies
• Organize and maintain data generated from new product testing
• Assist in maintaining Design History Files, Technical Files and other regulatory documents
• Assist in preparing regulatory submission documents
• Other duties, as assigned

QUALIFICATIONS

• Bachelor’s degree in science or combination of other education/job related experience
• Extremely organized with high attention to detail
• Effective written and oral communication skills
• Effective at multi-tasking
• Ability to work in a fast-paced, timeline-driven environment
• Ability to work independently and as part of a team
• Experience in medical devices a plus