Compliance Analyst
3 weeks ago
Job Description Job Title: Compliance Specialist
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.
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.
May serve as 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.
Complies with all health, safety and environmental policies.
Regulatory and Quality Management skills.
Customer service, Data analysis; Other Skills: MS Office, Written and verbal communication.
BS in clinical/medical, Engineering or science.
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, Clinical and Legal departments.
Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone.
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