Contract Regulatory Affairs Specialist: 510(k) Submissions

Integrated Resources Inc.; North Haven (CT); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Referral bonus of $500 per candidate

Job summary

A leading staffing firm seeks a Regulatory Affairs Specialist for a 7+ month contract in North Haven, CT, with a focus on preparing submissions and managing regulatory documentation. Candidates need to demonstrate familiarity with technical file remediation and project management software.

Qualifications

• Experience in compiling submissions and annual registrations.
• Overall knowledge of regulatory documentation is essential.
• Familiarity with Gantt charts and building regulatory plans preferred.

Responsibilities

• Compile materials for submissions, license renewals, and registrations.
• Prepare submission documents, including 510ks and change notices.
• Assist in technical file remediation processes.

Skills

Regulatory Documentation

Technical File Remediation

Filing 510ks

Change Notices

Microsoft Project

Job description

A leading staffing firm seeks a Regulatory Affairs Specialist for a 7+ month contract in North Haven, CT, with a focus on preparing submissions and managing regulatory documentation. Candidates need to demonstrate familiarity with technical file remediation and project management software.