Regulatory Affairs Specialist

The Regulatory Affairs Specialist provides primary RA support for one or more product line(s), region(s) and/or process/system. The RA Specialist may participate independently on new product development teams and provide continued RA support through the lifecycle of the product. The RA Specialist also prepares regulatory submissions required to market new or modified medical devices in global markets.

Requirements

• Understands fundamental global regulatory requirements and different regulatory pathways.
• Understands scientific and health principles related to healthcare product development and regulations.
• Participates in core teams as regulatory lead and provides guidance on regulatory requirements to product development teams, with some support from management.

Benefits

• Health insurance
• Retirement Plan
• Generous Paid Time Off
• Paid Holidays
• 401k Matching