Compliance Specialist

Compliance Specialist

A Few Words About Us - 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

• Support the Regulatory Compliance group by assisting in audit preparation, audit execution and closure.

• Responsible for executing weekly and monthly department reports and following up with action owners across the company to insure timely completion of activities.

• Create weekly/ monthly audit metrics reports and communicate results.

• Develop and perform audit trending reports.

• Review audit responses for adequacy of root cause investigation and GDP.

• Execute change process for Client audit procedures.

Qualifications

• Education (is a degree required or preferred, etc): Degree required

Technical Experience:

• CQA or ISO 13485 Lead Auditor Certification Required.

• Proficiency in Microsoft Xcel required.

• Knowledge/Experience with Medical Device Regulations (21 CFR 820 or ISO13485 ) preferred.

• Knowledge of Good Documentation Practices preferred.