Compliance Specialist

Compliance 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 Description

Job Title: Compliance Specialist

Location: Louisville, CO Duration: 6+ months (possibility of extension) ESSENTIAL DUTIES AND RESPONSIBILITIES:

• This individual will review, evaluate, and investigate product complaints relative to the identity, quality, reliability, safety, and effectiveness of Healthcare products.
• The Analyst will provide technical expertise and assistance in handling/categorizing complaints to comply with current FDA and international reporting regulations.
• Duties also include compliance tracking, trend analysis and reporting to Management.
• This individual must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective.

JOB QUALIFICATIONS:

• Evaluates incoming complaint information and maintains it in the electronic database.
• Determines reportability (MDR/AE) of complaints to FDA and other international regulatory agencies.
• Works closely with customers and sales representatives to respond to complaint reports.
• Closely monitors quality, completeness and timeliness of complaint investigations and files.
• Reviews, tracks, trends, analyzes and reports on complaint data to Management and other departments as needed.
• Works with cross functional teams to ensure proper communication and evaluation/investigation of customer issues.
• Participates in team decision making and displays team problem solving/communication skills.
• Prepares and presents information in meetings and to upper Management
• May serve a team member on projects/programs.
• May provide guidance and training to support staff and new analysts.
• May visit customer sites to meet with staff to discuss complaint issues.
• May take lead on specific complaint issues and coordinate with other departments to further investigate.
• May create/ or be responsible for revision of procedures/processes
• Ad hoc reporting.
• Complies with all health, safety and environmental policies.

PREFERRED SKILLS/QUALIFICATIONS :

Regulatory and Quality Management skills

SKILLS/COMPETENCIES :

• Customer service, Data analysis; Basic understandings of industry practices and standards; Other Skills: MS Office, Written and verbal communication;

EDUCATION:

• BS in clinical/medical, Engineering or science

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

• Reports to Senior Analyst/Supervisor/Manager position as applicable.
• Works closely with other local QA, International RA/QA, Sales, Marketing, Customer Service, R&D, Manufacturing, Engineering, Clinicals and Legal departments.

WORKING ENVIRONMENT/PHYSICAL ACTIVITIES :

• Usual Office environment with frequent Sitting, walking, standing, kneeling, crouching, crawling, balancing, stooping and occasional Climbing.
• Frequent use of eye, hand and finger coordination enabling use of Office machinery.
• Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone.
• Light physical effort required by handling objects up to 20 pounds occasionally* and/or up to 10 pounds frequently.
• *Occasional: Activity exists less than 1/3 of the time.
• Frequent: Activity exists between 1/3 and 2/3 of the time.