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!

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