Senior Compliant Investigator, PMC
$65,000–$70,000 year
On-siteMiramar, Florida, United States
Job Summary
Manage the complaint handling reporting system by tracking and trending daily, weekly, and monthly reports to support submissions to regulatory agencies and partners. Conduct multidisciplinary investigations for critical complaints with market impact, initiating root cause analysis and coordinating corrective and preventative actions with subject matter experts. Ensure all investigations adhere to FDA rules and maintain required cycle times using a validated database. Support the compilation of Annual Product Reviews and facilitate timely submissions of periodic reports for marketing applications. Participate in regulatory inspections and audits, serving as a primary contact or team coordinator as needed.
Required Qualifications
- High school diploma or general education degree (GED)
- Associate or Bachelor in scientific/medical discipline
- Minimum of 3-5 years experience in Post Market Compliance or Quality Assurance
- Management of customer complaint processes
- GCPs
- GMPs
- GLPs
- post-market safety and surveillance compliance
- Ability to communicate well in person and in writing with senior management and regulatory authorities
- Computer literate in a Windows environment with the ability to use electronic mail system, the Internet and the Microsoft Office Suite including Excel, Word, Power Point and Access
- Competency in writing reports in the English language
- Strong organizational skills
- Ability to work under minimal supervision and rely on experience and good judgment to plan and accomplish assigned goals
- Able to manage multiple tasks simultaneously, be responsive and adaptable to project/task change based on business requirements
- Strong interpersonal skills to interface with many levels of an organization
- Ability to perform tasks of substantial variety and complexity and to serve as a resource in the resolution of problems and issues
- Ability to adapt procedures, techniques, tools, materials, and/or equipment to meet special needs
- Coordinating, delegating assignments, training, coaching and reviewing the work of peers
- Proficiency in SAP, TrackWise, Word, Excel, Access and ability to learn other software
- Ability to sit
- Ability to use hands to finger, handle, or feel and reach with hands and arms
- Ability to talk or hear
- Ability to occasionally stand and walk
- Ability to occasionally lift and/or move up to 10 pounds
- Depth perception
- Ability to adjust focus
Desired Qualifications
- Associate or Bachelor in scientific/medical discipline
- Knowledge of transdermal
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