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Job Description

Day to Day:

Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.

Key Responsibilities:

* Leads efforts for complaint handling of customer responses including medical device incident reporting.

* Review customer feedback and requests and then assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.

* Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.

* Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff.

* Ensure that the correct documentation is in place at point of use in the Complaint.

* Prepare and present reports and status information to management as needed

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

- Bachelors Degree

- 2-3 years of experience as a Business Analyst

- Experience in complaint handling

- Team players with excellent coordination, interpersonal and communication skills

- Self-directed requiring minimal supervision

- Microsoft proficiency - Previous Quality Assurance or complaint handling experiences preferred

- High level of proficiency with Microsoft (MS) Office applications (Excel, Word, Outlook). null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.