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.