Compliance Specialist

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.
  
  

Qualifications

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)