Job Description
Job Details
Job Location
Elyria, OH
Remote Type
Fully Remote
Description
Summary:The Specialist, Complaint Handling IV is responsible for compiling adverse event investigation information, reviewing potential reportable events to determine if regulatory filings are required, and ensuring compliance with all Federal and International regulations as they apply to medical devices manufactured or imported by Invacare.
Essential Functions:
Maintain complete complaint files for all customer complaints, according to Invacare procedures and work instructions.
Review all received complaints for regulatory reporting requirements (MDR/AE) within timeframes mandated by Invacare procedures and work instructions.
Initiate and complete MedWatch reports for timely submission to the FDA or as procedures require to other official regulatory authorities.
Investigate specific events by contacting internal resources, Invacare field personnel and/or distributors/customers as appropriate
When available, review the retuned product evaluation results for possible contribution to the complaint investigation
Ensure that decisions regarding MDR reporting are accurately and consistently documented within the complaint database.
Review and approve child records (3500A forms and Canadian filings). Submit child records to applicable regulatory bodies.
Support development of OEM and FDA notifications as per 21 CFR 803.
Ensure all necessary updates and corrections have been made prior to closure. Close complaint records once complete.
Maintain awareness of new products, government regulations and requirements
Provide input on methods to maintain MDR/AE compliance continuously
Keep updated and share knowledge on changing regulatory policies with the department
Complete all required training applicable to assigned position.
Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required.
Qualifications
Qualifications:
Bachelor's degree in science, engineering, or equivalent years of relevant experience and/or education.
Minimum of (3) years of experience within regulatory affairs or medical documentation and reporting; medical device experience preferred.
Experience in the medical field and or understanding of medical terminology and language. Clinical experience preferred.
Knowledge of 21 CFR 803/806/820, ISO 135485 and MEDDEV 2.12-1
Professional certification by AORN, AACN, ENA or other nationally recognized body preferred
Strong communication, analytical, organizational and management skills
Working knowledge of, or previous experience with Invacare's portfolio of products is preferred.
Ability to work hours and shifts between 8 a.m. and 8 p.m.
Proficiency with MS Office, MS Project, Visio, electronic document management
An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet
