Regulatory Affairs Specialist Job at Astrix, Fort Worth, TX

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  • Astrix
  • Fort Worth, TX

Job Description

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-liv e
  • 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!

Job Tags

Local area,

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