
Regulatory Affairs Specialist II (REMOTE USA)
Tap Growth ai
Full time
Software Development
United States
Hiring from: United States
We're Hiring: Regulatory Affairs Specialist II!
We are seeking to hire a Regulatory Affairs Specialist II in Remote in USA.
Location: 100% remote, USA
Work Mode: Work from anywhere
Role: Regulatory Affairs Specialist II
Pay Scale: $100, 214 – $117, 339 (Dependent on Experience)
What You'll Do
∙ 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
What We're Looking For
∙ Bachelor's Degree (no specific field of study)
∙ ED MDR
∙ Medical Devise Regulatory experience
Why Choose Us?
As an employee, you have access to a comprehensive benefits package including:
∙Medical insurance – PPO, HMO & HSA
∙Dental & Vision insurance
∙401k plan
∙Employee Assistance Program
∙Long-term disability
∙Weekly payroll
∙Expense reimbursement
∙Online timecard approval
Ready to make an impact? Apply now and let's grow together!
We are seeking to hire a Regulatory Affairs Specialist II in Remote in USA.
Location: 100% remote, USA
Work Mode: Work from anywhere
Role: Regulatory Affairs Specialist II
Pay Scale: $100, 214 – $117, 339 (Dependent on Experience)
What You'll Do
∙ 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
What We're Looking For
∙ Bachelor's Degree (no specific field of study)
∙ ED MDR
∙ Medical Devise Regulatory experience
Why Choose Us?
As an employee, you have access to a comprehensive benefits package including:
∙Medical insurance – PPO, HMO & HSA
∙Dental & Vision insurance
∙401k plan
∙Employee Assistance Program
∙Long-term disability
∙Weekly payroll
∙Expense reimbursement
∙Online timecard approval
Ready to make an impact? Apply now and let's grow together!
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