Our client is one of the global leaders in the medical device industry, seeking to hire a Complaint Analyst Associate in the Quality and Regulatory Affairs Department. The primary function of this position is complaint handling but also includes, but is not limited to, processing Medical Device Reports, assisting with recalls, internal/external audit support and related activities, and misc./routine regulatory support for US and Canada. This includes investigating, sourcing, drafting, reviewing, all information supporting these activities, when directed. Hours are Monday - Friday, 8:00am - 5:00pm, after 2 month training period hybrid schedule 3/2. Hourly pay is dependent on experience.

Responsibilities:
- Process complaints from various sources (direct from customers, field employees, Technical Support teams, etc.) and any corresponding Medical Device Reports in the established time frames.
- Source and utilize technical data (e.G., primarily historical complaints, and in some cases quality data such as CAP A) and prepare complaint files in accordance with established procedures.
- Assist colleagues in MRNA and MRSZ to determine the root cause of failures, suggest investigation approaches as they relate to complaint activities, as appropriate. Review and provide feedback on
- Clinical Investigations Reports.
- Draft customer letters as needed to support complaint files.
- Provide misc./routing Quality and Regulatory Affairs support (e.G., state license renewal, certificate folder management, etc.), when directed.
- Continuously evaluate and provide suggestions on improving the complaint handling process and other assigned activities.
- Assist with the preparation of recall documentation (assist with product affected list, mailing customer letter and follow up tracking, drafting monthly notifications, close out reports), as directed.

Qualifications:
- Bachelors Degree or equivalent combination of education and experience
- Minimum of 3 years in medical devices or other regulated industries
- Knowledge of 21 CFR 820 and ISO 13485, at a minimum related to complain handling
- Ability to work in a fast-paced environment, high output, team oriented environment
- Excellent organizational, analytical, and writing skills required
- Excellent computer skills, word processing, spreadsheets, etc