Compliance Specialist

posted:
Location
Boise, Idaho
Industry
Customer Service & Call Center (Office and Administrative Support Occupations)
Job Type
Temp to Perm
Working Hours
8:00 AM - 5:00 PM
Salary
US$ 16.00 - US$ 21.00 per hour
Ref. Number
S_64396
Contact
Larson,Cori, Spherion
Phone
208-514-2044
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Job Description

Responsible for receiving, processing, analyzing and reporting product complaints as required for procedural compliance with applicable regulations. Collaborates with Customer Technical Support, Clinical, Failure Investigation, Risk Management, and other internal groups to support the Complaint Management functions

Responsibilities:
???Responsible for end-to-end medical device complaint handling processes.
???Gathers all complaint data to ensure the complaint file is complete.
???Reviews and is responsible for the closure of customer complaints.
???Maintains and analyzes complaint data to identify and report recurring issues to the quality complaint management team.
???Documents and tracks contact information, reported issues and problems in accordance with company guidelines and external regulatory requirements.
???Participates in investigation tracking and trending activities for reporting purposes.
???Provides adverse event reporting to applicable regulatory agencies / Notified Bodies, including filing Medical Device Reports (MDRs) / Incident Reports, supplemental reports, etc.
???Mentors assigned support staff (Complaint Management Associates) on the process for drafting and submitting MDRs.
???Partners with assigned Complaint Management Associate to ensure shared workload is managed within the required timelines.
???Maintains databases specific to Complaint tracking, trending, and failure investigation results.
???Confirms completion of required training plan before assuming job responsibilities.
???Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

Working hours: 8:00 AM - 5:00 PM

Skills:
--Ability to determine if reported issues are reportable based on applicable regulations.
--Ability to review extensive complaint information, think critically and determine the best course of action.
--Excellent written communication skills with the ability to write business and technical documents.
--Skilled at documenting events and findings effectively and efficiently.
--Skilled at clearly conveying knowledge to complaint management.
--Skilled at creating a cooperative team environment.
--Able to review, trend, analyze and report data using databases and/or Excel.
--Strong computer skills, including Microsoft Word, PowerPoint and Excel.
--Excellent at time management.
--Excellent organizational and prioritization skills.

Education:
Bachelors

Experience:
1-4 years

Qualifications:
Bachelors Degree
1+ years compliance expierence


Please call or text 208-514-2044 to schedule an interview

Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.

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