Regulatory Affairs Specialist - Astrix : Job Details

Exciting Regulatory Affairs Specialist II development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.

Location: Fort Worth - Remote (Preference given to DFW locals)

Duration: 12 months

Pay Rate: 40.00-55.00 DOE

Regulatory Affairs Specialist II

• Update technical documentation files to align with EU MDR medical device requirements
• Submit Regulatory Impact Assessments to countries using Veeva system and ensure completeness of assessment from countries
• Coordinate submission package
• Manage country timelines to support approval of lifecycle management changes for medical devices
• Collect data from Technical Documentation File in preparation for Eudamed go-live
• Verify registration data in Veeva database for US and Canada medical devices
• EU MDR
• Medical Device Regulatory experience
• Bachelor's Degree

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!