Regulatory Affairs Specialist
Careers Integrated Resources Inc • North Haven, CT, United States
2 days ago
Job type
- Full-time
Job description
Regulatory Affairs Specialist
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 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.