Regulatory Complaint Analyst

Regulatory Complaint Analyst

Title: Regulatory Complaint Analyst
Location: United States-California-Santa Clara County-Sunnyvale
Job Number:_130037
Primary Function of Position: The Regulatory Complaint Analyst reviews new complaints for MDR eligibility, codes customer complaints and ensures completeness and consistency of the documentation. Position may also be responsible for some regulatory reporting. The candidate will prepare failure analysis responses for customers and close non reportable complaints. In addition, the candidate will provide analysis of quality data to support Regulatory Compliance activities including quarterly Quality Review Board Meetings, and work with Engineering and Product Quality to formulate and write responses.
Roles and Responsibilities:
This position has responsibility for:
* Investigate complaints daily:
* Perform the preliminary classification of the complaints and elevate complaints that require reporting for additional review
* Evaluate documentation for completeness and consistency, and execute additional actions as necessary to close the complaint file
* Expedites product Complaint to conform to company''s Complaint policy and procedures.
* Maintaining oversight of the Issue / Complaint Handling daily processes to ensure issues are being addressed in a timely and compliant manner.
* Approve final complaint file for closure
* Write, review, and file Medical Device Reports (MDRs) and Vigilance Reports where requested.
* Identify and elevate new failure modes when encountered and work with Product Quality group to assign new failure codes
* Assist in the organization and provision of complaint data for the PIR (Product Inquiry Report) process.
* Analyzes and trends Complaint data monthly to identify new issues or systemic discrepancies as necessary.
* Establish and prepare Quality Review Board metrics for the Regulatory Compliance group.
* Participate in new hire training and continuous Regulatory Compliance training as required
* Prepare responses to customer requests for failure analysis as necessary
* Represent Regulatory Compliance at selected cross functional meetings
* Perform other duties as assigned
Qualifications:
Skill/Job Requirements:
Education:Undergraduate degree in engineering, life science, or equivalent
Experience:3-5 years experience in medical device field, with experience in the following areas:
* Investigation of complaints and complaint file documentation
* Filing of Medical Device Reports (MDRs) with FDA and EU Vigilance Reports with EU Notified Bodies
Skills:
* Demonstrated cross functional communication skills
* Strong computer skills
* Demonstrated written and verbal communication skills
* Demonstrated independent worker with ability to focus
* Demonstrated attention to detail
Competency / Training:
* Firm understanding of Intuitive Surgical complaints system and process
* Able to retrieve and attached appropriate internal and external documentation to electronic complaint file
* Firm understanding of quality records requirements and how they apply to Intuitive Surgical complaint files
* Firm understanding of regulatory reporting requirements in markets served.
Travel:Occasional hospital site visits/meetings
Job: Clinical / Regulatory