Regulatory affairs specialist Job at Sunrise Systems Inc, Fort Worth, TX

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  • Sunrise Systems Inc
  • Fort Worth, TX

Job Description

Job Title: Regulatory Affairs Specialist II
Job ID: 24-03395
Location: Remote
Duration: 12 Months contract on W2
  • ED MDR
  • Medical Devise Regulatory experience
  • Bachelor's Degree (no specific field of study)
  • Under guidance, 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 and manage. country timelines to support approval of lifecycle management changes for medical devices
  • Under guidance, collect data from Technical Documentation File in preparation for Eudamed go-live.
  • Verify registration data in Veeva database for US and Canada medical devices.
It's a bonus if they are local to Dallas-Fort Worth and can come into the Fort Worth office periodically. Contact:
Durga Prasad: Durgaprasad.B@sunrisesys.com | 732 313 0251 |
Or
Contact: Sharath Babu: 732-272-0341 | |

Job Tags

Full time, Contract work, Local area, Remote job,

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