Regulatory Affairs Specialist

Regulatory Affairs Specialist responsible for developing regulatory strategies, preparing U.S. and international submissions, and obtaining and maintaining approval for products to markets worldwide.

Requirements

• Bachelor's degree and a minimum of 2 years of regulatory experience or an advanced degree with a minimum of 1 years of regulatory experience.
• Experience with FDA Class II or III devices or experience with EU Class IIb or III devices.
• Experience working with cross-functional teams.
• Ability to comprehend principles of engineering, physiology, and medical device use.
• Ability to effectively manage and prioritize numerous projects and responsibilities.

Benefits

• Comprehensive Medical, Dental, and Vision
• Life Insurance
• Supplemental Benefits
• 401(k) with both Traditional and Roth options available
• Employee Stock Purchase Plan (ESPP)
• 10 Paid Company Holidays
• Competitive PTO plan
• Tuition Reimbursement