Job Summary
A staffing agency is searching for a person to fill their position for a Remote Senior Regulatory Affairs Specialist.
Core Responsibilities Include:
- Preparing regulatory assessments of product changes
- Documenting rationale, actions and following through with notifications internationally as needed
- Authoring of 510(k), MDP transition, PMA, EU IVDR, EUMDR authorizing experience
Applicants must meet the following qualifications:
- Experience in interacting with FDA staff notified bodies
- Demonstrated success in securing regulatory approvals
- Great communication skills
- Ability to work in a fast paced environments