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3 months ago
Job Description:
- $23 - $25/hour based on experience, W2
- Hybrid (3 days on-site, 2 days remote), Monday - Friday 8:00AM - 5:00PM.
- 5 days on-site at the start of the position (for training)
Responsible for:
- Support department processes and workflow: including, processing outgoing faxes, incoming mail, performing data entry, filing, and copying.
- Initiating and processing follow up activities to gather information, submit notifications, etc.
- Inform internal and/or external customers of the device tracking requirements.
- Ability to monitor several files at once, including status and follow-up, as necessary.
- Respond to verbal and written requests from internal and external customers. Initiate and set up complaint files.
- Maintain and update database.
- Record all complaint activity in both hard copy (when applicable) and computer files, following complaint handling regulations 21 CFR 820.198, and SOR/98-282, and internal procedures.
- Ability to identify non-complaint customers and forward to management for resolution.
Qualifications:
- Associate's degree, with three to five years previous experience in regulatory, quality, clinical, or related customer service setting; or equivalent combination of education and experience. Bachelor's degree is strongly preferred.
- Best industies are anything healthcare related - insurance - pharmacy call center - large law office experience also works very well
- Ability to function in a controlled environment by the FDA and other regulatory authorities.
- Ability to communicate effectively, both verbally and in writing.
- Ability to handle restricted, confidential, private, or personal information in accordance with departmental policies, HIPAA, and related international standards.
- Ability to use word processing, spreadsheet, and database applications.
- Ability to learn various software programs.