Regulatory Affairs Specialist

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

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Job Title:Regulatory Affairs Specialist

Location:North Haven, CT
Duration:7+ months(Possibility of extension)

Job Roles & Responsibilities

• Compiles all materials required in submissions, license renewal, and annual registration.
• Technical file remediation, DHF experience, Microsoft project experience a plus as we need to build regulatory plans in Gantt.
• Assist in submission preparation (e.g. 510ks, Change Notices to Notified Bodies). Overall knowledge of regulatory documentation.
  

Additional Information

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Thanks & Regards,

Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732-844-8724
Email id – seema @irionline.com| www.irionline.com
LinkedIn: https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)