Sr. Manager, Complaint Handling

Main Job Responsibilities / Competencies

• Manage all aspects of complaint handling team activities to ensure compliance with applicable regulations and Company quality system requirements.
• Adequately train complaint handling personnel in procedures relevant to their activities.
• Act as company liaison with regulatory agencies, including the FDA, Notified Body, and other governmental agencies, regarding communications related to complaints and audits.
• Provide complaint data and analysis to the Post-Market Surveillance system, including maintenance, monitoring, trending, and presentation of data for evaluation by the Device Safety Committee.
• Maintain, monitor, and trend clinical studies data and present it to the Device Safety Committee for evaluation.
• Report status of complaint handling and clinical studies processes to Executive Management.
• Support medical affairs activities as requested.

Requirements

• B.A./B.S. degree in a scientific field.
• Minimum 5 years’ experience in an FDA-regulated environment, preferably with quality management experience.
• Experience with the review, statistical analysis, and presentation of scientific data.

Skills

• Strong statistical, analytical, and data-processing skills.
• Excellent written and oral communication, and technical writing and editing skills.
• Ability to manage and prioritize multiple projects and organize departmental resources.

Pay

Pay range is $160K - $190K. Final compensation will depend on experience.