R&D Partners is seeking to hire a Regulatory Affairs Specialist II in Remote, US.
Your main responsibilities as a Regulatory Affairs Specialist II:
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
Why Choose R&D Partners ?
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
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.
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