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!
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Company : ABC Nova Scotia Join ABC Fitness, the leading technology provider for the fitness industry! Job Description Join ABC Fitness and become part of a culture that’s as ambitious as it is authentic. Let’s transform the future of fitness—together!...
Software Development
Canada
Hiring from: Canada
It’s incongruous that setting up infrastructure as foundational as business internet connectivity is so expensive, complex, and often takes months. We believe that enterprise-grade networking will become the next utility, where a business can sign a lease and get connected...
Software Development
United States
Hiring from: United States
Take your career to new heights with Loopio! We are looking for a driven and highly-organized team member to join our Revenue Operations team. As the Revenue Operations Analyst with a focus on our key customer experience platforms, your focus...
Software Development
Canada
Hiring from: Canada