Senior Compliance Specialist

Key Duties and Responsibilities:

• Coordinate the full complaint lifecycle, including intake, tracking, investigation, and closure, working closely with cross-functional partners
• Ensure complaints are accurately documented, appropriately categorized, and progressed within required regulatory and internal timelines
• Review complaint responses for accuracy, completeness, clarity, tone, and regulatory compliance prior to finalization
• Monitor complaint data to identify trends, potential root causes, and emerging risks; support cross-functional teams in identifying and tracking corrective and preventive actions
• Facilitate monthly complaint review meetings by preparing metrics, dashboards, and summary reports for leadership, compliance committees, and regulatory audiences
• Support the maintenance and continuous improvement of complaint-related policies, procedures, workflows, and internal controls
• Assist with the evaluation, documentation, and reporting of safety alerts and recalls, as applicable
• Support Post-Market Surveillance activities, including contributions to Periodic Safety Update Reports (PSURs).
• Participate in CAPA review meetings and support timely CAPA implementation and closure activities
• Obtain internal auditor certification and assist with internal audits and, as appropriate, supplier audits
• Provide support for regulatory submissions and responses, as needed
• Perform additional responsibilities as assigned by management

What we expect from you:

• College degree or equivalent experience
• 3-5 years’ experience with complaint processing
• Solid understanding of ISO 13485, FDA, and MDR standards and regulations 
• Strong attention to detail with advanced written and verbal communication skills 
• Effective problem-solver who can manage multiple priorities
• Adaptable, resourceful, and able to work independently

Working Conditions:

• Normal office conditions – hybrid work environment available 
• Must be able to sit/stand/walk 8 hours per day
• Position may require travel 1-2 times per year
• May be required to be fully vaccinated against the COVID-19 virus and other diseases