Senior Compliant Investigator, PMC

Aveva Drug Delivery Systems Inc; Florida; On-site; USD 90,000 - 130,000; Full time

Job summary

Aveva Drug Delivery Systems Inc in Florida is seeking a Senior Investigator in Post-Market Compliance to lead complaint investigations, track trends, and ensure FDA-aligned documentation. You will manage the complaints database, coordinate with QA, and support APRs for commercial products.

Ideal candidates have 3–5 years in post-market compliance or quality assurance, strong written communication, and proficiency with SAP and TrackWise.

Qualifications

• Ability to communicate well in writing with regulatory authorities and senior management.

Responsibilities

• Manage complaint handling reporting system and interface with management, partners, contractors, and regulators.
• Conduct multidisciplinary investigations and ensure timely completion per requirements.
• Identify root causes and implement corrective/preventive actions.
• Prepare and submit Periodic Reports and Annual Reviews as assigned.
• Support audits and inspections as needed.

Skills

Communication

Microsoft Office

Excel

Word/PowerPoint/Access

SAP

TrackWise

Reporting

Organizational skills

Multitasking

Education

GED or higher

Scientific/medical degree

Tools

SAP

TrackWise

MS Office

Job description

Job DescriptionJob Title (Internal)Senior Investigator, Post - Market ComplianceJob Profile/Level:Line of Business (LOB) or Business Process Stream (BPS)Department/Org Unit:QualityReports Directly To:Manager, QA Compliance and Risk ManagementReports Indirectly To:People LeaderYes NoNumber of Direct Reports and Job TitlesRevision Date(Month / Day / Year)10/2025Revision Number:Job Location:Travel RequirementsYesNo[ X]Job Summary:The Senior PMC Investigator is responsible for daily, weekly, and monthly tracking and trending reports of complaints, to support reporting to Aveva Management (Quality Council) as appropriate, and communication to partners/clients, and regulatory agencies. The Senior Investigator is responsible for the timely initiation and for conducting multidisciplinary investigations required in support of complaints, maintaining required cycle times and documenting the investigation results using a validated customer complaints database in compliance with FDA rules, regulations, and expectation.The Senior Investigator supports the compilation of the Annual Product Reviews (APRs) for the commercial products manufactured at Aveva within the required APRs process timelines.Job Responsibilities:Manages the complaint handling reporting system, including interacting with management, partners, contractors, and regulatory agencies.Ensures all critical investigations that have potential market impact following the internal escalation procedure.Conducts complaint investigations; ensures multidisciplinary investigations are initiated and completed per requirementsRecognizes critical path for complaint investigations and liaises with appropriate Subject Matter Experts to ensure timely support to complaint investigations to identify, root cause, corrective & preventative actions.Maintains compliance with procedures and reports, performs weekly, monthly, and other periodic exchanges per regulatory requirements and agreements to ensure compliance with reconciliation requirements for complaintsAnalyzes data and reports trends in quality systems and communicate to management team as required.Supports timely submission of Periodic Reports, Annual Reports, and other submissions as assigned for Aveva-owned marketing applications to managementParticipates in inspections by regulatory agencies and auditors, and can serve as primary contact or inspection team coordinatorWorks as a member of a team to achieve all outcomesOperates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirementsPerforms all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;All other duties as assigned.Job RequirementsEducationHigh school diploma or general education degree (GED), (Associate or Bachelor in scientific/medical discipline preferred)Knowledge, Skills and AbilitiesAbility to communicate well in person and in writing with senior management and regulatory authoritiesComputer 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 AccessCompetency in writing reports in the English languageStrong organizational skillsAbility to work under minimal supervision and rely on experience and good judgment to plan and accomplish assigned goalsAble to manage multiple tasks simultaneously, be responsive and adaptable to project/task change based on business requirementsStrong interpersonal skills to interface with many levels of an organizationAbility to perform tasks of substantial variety and complexity and to serve as a resource in the resolution of problems and issuesAbility to adapt procedures, techniques, tools, materials, and/or equipment to meet special needsCoordinating, delegating assignments, training, coaching and reviewing the work of peersProficiency in SAP, TrackWise, Word, Excel, Access and ability to learn other software.While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel and reach with hands and arms. The incumbent is frequently required to talk or hear and occasionally required to stand and walk. The incumbent must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include depth perception and ability to adjust focus.Knowledge of transdermal (desired)ExperienceA mminimum of 3-5 years experience in Post Market Compliance or Quality Assurance.Management of customer complaint processes, GCPs, GMPs, GLPs, and post-market safety and surveillance complianceEducationHigh school diploma or general education degree (GED), (Associate or Bachelor in scientific/medical discipline preferred)Knowledge, Skills and AbilitiesAbility to communicate well in person and in writing with senior management and regulatory authoritiesComputer 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 AccessCompetency in writing reports in the English languageStrong organizational skillsAbility to work under minimal supervision and rely on experience and good judgment to plan and accomplish assigned goalsAble to manage multiple tasks simultaneously, be responsive and adaptable to project/task change based on business requirementsStrong interpersonal skills to interface with many levels of an organizationAbility to perform tasks of substantial variety and complexity and to serve as a resource in the resolution of problems and issuesAbility to adapt procedures, techniques, tools, materials, and/or equipment to meet special needsCoordinating, delegating assignments, training, coaching and reviewing the work of peersProficiency in SAP, TrackWise, Word, Excel, Access and ability to learn other software.While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel and reach with hands and arms. The incumbent is frequently required to talk or hear and occasionally required to stand and walk. The incumbent must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include depth perception and ability to adjust focus.Knowledge of transdermal (desired)ExperienceA mminimum of 3-5 years experience in Post Market Compliance or Quality Assurance.Management of customer complaint processes, GCPs, GMPs, GLPs, and post-market safety and surveillance compliance